The Medical Product Safety Network (MedSun) is an adverse event reporting program launched by the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH).
John Snow Labs Standard End User License Agreement
Last updated:January 20, 2021
This Standard End User License Agreement (“EULA”) applies to customers of John Snow Labs Inc. (as defined below), using any product of John Snow Labs Inc. on John Snow Labs Marketplace as defined below (hereinafter referred to “you”) and John Snow Labs Inc., a Delaware corporation (“John Snow Labs”, “we” or “us”).
By downloading, installing, and/or using (as applicable) any Product of John Snow Labs (as defined below), you automatically agree to be bound by, and use our Products in compliance with, this EULA. This EULA, together with additional terms and conditions and/or policies referenced herein or located on https://www.johnsnowlabs.com and/or conveyed to you by John Snow Labs, is a legally binding contract between you and John Snow Labs.
PLEASE READ THIS EULA CAREFULLY BEFORE PURCHASING, INSTALLING OR USING OUR PRODUCTS MADE AVAILABLE ON JOHN SNOW LABS MARKETPLACE.
We may make changes to this EULA from time to time. When we do so, we will revise the “last updated” date given above. The then-current version of this EULA will supersede all earlier versions. You agree that your continued use of our Products after such changes have been published to our EULA will constitute your acceptance of such revised EULA.
“Products” means products and services of John Snow Labs that you download and use from listings in John Snow Labs Data Library;
Important Notice
By installing and using our Products, you acknowledge that the use of the Products can be subject to the restrictions and controls imposed by United States export regulations.
You represent and warrant that you do not intend to use the Products for any purpose prohibited by United States export regulations, including, without limitation, terrorism, cyber-attacks, cyber-crimes, money-laundering, industrial espionage, or nuclear, chemical or biological weapons proliferation. Further, you represent and warrant that you are not listed as a denied party on any list governing United States exports.
Eligibility
Our Products can be used by an individual, business or other legal entity, or both. If you are entering into this EULA, or using the Products, on behalf of a company or other legal entity, you represent that you have the authority to bind such entity to this EULA, in which case “you” shall refer to such entity.
In the event you have entered into a separate written agreement with John Snow Labs regarding the Products that contemplates terms that are inconsistent with this EULA, the written agreement shall control and this EULA will not apply to you to the extent inconsistent with such written agreement, or, if such written agreement is contemplated to be in lieu of this EULA, then this EULA shall not apply at all.
Your Access and Use
Subject to your compliance with this EULA, as well as any other applicable policies, John Snow Labs grants you non-exclusive, non-transferable, license to install, access to, modify, and use of, the Products worldwide (subject to applicable export laws) during the term of this EULA (as described below) solely for research, private study and personal use of Products.
This license is personal to you, and you may not resell our Products, permit other users access to our Products through your account. Your right to use our Products is limited by all terms and conditions set forth in this EULA.
Except for your pre-existing rights and this license granted to you, we and our licensors retain all rights, titles and interests in and to our Products, all related intellectual property rights, including trademarks (whether registered or pending), domain and business names. Our Products are protected by applicable intellectual property laws, including United States copyright law and international treaties.
Except for the foregoing license, you have no other rights in the Products and you may not modify, edit, copy, reproduce, create derivative works of, reverse engineer, alter, enhance or in any way exploit the Products in any manner. If you breach any of this EULA, the above license will terminate automatically.
You will be deemed to have taken any action that you permit, assist or facilitate any person or entity to take related to this EULA, your content or use of the Products. You are responsible for end users’ use of your content and the Products. You will ensure that all end users comply with your obligations under this EULA and that the terms of your agreement with each end user are consistent with this EULA. If you become aware of any violation of your obligations under this EULA caused by an end user, you will immediately suspend access to your content and the Products by such end user. We do not provide any support or services to end users unless we have a separate agreement with you or an end user obligating us to provide such support or services.
Restrictions
You will access or use our Products solely via John Snow Labs Data Library.
Except as otherwise explicitly provided in this EULA or as may be expressly permitted by applicable law, you will not, and will not permit or authorize any third party to:
reproduce, modify, translate, enhance, decompile, disassemble, reverse engineer or create derivative works of any of our Products or its technological features or measures;
rent, lease, sell, resell, loan, distribute, or sublicense access to any of our Products;
circumvent or disable any security or technological features or measures of our Products;
use our intellectual property rights without our express prior written authorization;
use our Products for more than one trial period, unless the trial period is extended by John Snow Labs’ prior written permit;
use our Products with an intent to build a competitive product or service, or copy or substantially copy any ideas, features, functions, organization, structure, application program interface, graphics, or user interface of the Products;
store, copy, modify, distribute, or resell any of the information; audio, visual, and audiovisual works, or other content made available on our Products (collectively, “Content”) or compile or collect any Content as part of a database or other work;
use any automated tool (e.g., robots, spiders) to access or use our Products, or to store, copy, modify, distribute, or resell any Content;
circumvent or disable any rights management, usage rules, or other security features of our Products;
use our Products in a manner that overburdens, or that threatens the integrity, performance, or availability of, our Products; or
remove, alter, or obscure any proprietary notices (including copyright and trademark notices) on any portion of our Products or any Content.
Fees and Taxes
Your use of the Products is subject to our fees. All fees are given on our website https://www.johnsnowlabs.com. Except as set forth in this EULA, the fees are non-refundable. We are entitled to revise our fees from time to time.
The fees exclude any federal, state or local taxes, VAT, GST, or similar taxes. You are responsible for identification and payment of all taxes as required by applicable law.
Term and Termination
This EULA will become effective as of the date of your order of Products and shall be in effect until terminated.
John Snow Labs may suspend or terminate your right to use our Products, if you or your end user’s use of the Products:
is in breach of this EULA;
poses a security risk to our Products;
could adversely impact our systems, the Products or other customers;
could subject us, our affiliates, or any third party to liability; or
could be fraudulent.
We may also suspend or terminate your right to use our Products, if you fail to perform your payment obligations, or you have ceased to operate in the ordinary course, made an assignment for the benefit of creditors or similar disposition of your assets, or become the subject of any bankruptcy, reorganization, liquidation, dissolution or similar proceeding.
We may also suspend or terminate your right to use our Products without any reason upon a relevant 30 days’ written notice to you and will refund the unused fees pre-paid by you for access to the Products for the affected time period (if any). Where your access is suspended or terminated by the breach of this EULA or applicable laws, John Snow Labs will will not provide, or be liable for, any refund.
You will cease use of the Products during any period of suspension, or upon termination of this EULA.
All provisions which by their nature are intended to survive termination shall survive termination of this EULA.
Support
If applicable to your Product, John Snow Labs will provide you with the support services. If you use a trial access, support services are excluded. Under this EULA, our support services exclude any installation, training, maintenance services (including any error corrections, bug fixes, or new releases), technical assistance, consulting services, or other services of any kind. Such services are provided at John Snow Labs’ discretion.
From time to time John Snow Labs can perform updates to our software. If available, such updates may include bug fixes, new features and/or enhancements. You are solely responsible for deploying such updates at your own risk and liability.
Access to our Products
We do not provide you with the equipment to access our Products. You are responsible for all fees charged by third parties related to your access and use of our Products (e.g., charges by Internet service providers).
You are responsible for monitoring your use of the Products, including payment of all fees and/or taxes related to such access and use. You agree that John Snow Labs is permitted to request and you hereby consent to provide John Snow Labs information related to your use of the Products for auditing purposes.
You also certify that you are legally permitted to use the Products, and take full responsibility for the selection and use of the Products. This EULA is void where prohibited by law, and the right to use the Products is revoked in such jurisdictions. John Snow Labs makes no claim that the Products may be lawfully used outside of the United States. If you use the Products from outside of the United States, you do so at your own risk and you are responsible for compliance with the laws of jurisdiction.
Privacy Policy
We may collect, store and receive personal and other information about you through our Products. Our collection and use of this information is governed by our Privacy Policy available at https://www.JohnSnowLabs.com/privacy/ which may be amended from time to time.
Links and Third Party Content
Our Products may display, or contain links to, third party products, services, and websites. Any opinions, advice, statements, services, offers, or other information that constitutes part of the content expressed, authored, or made available by other users or other third parties, or which is accessible through or may be located using our Products (collectively, “Third Party Content”) are those of the respective authors or producers and not of us or our shareholders, directors, officers, employees, agents, or representatives.
We do not control Third Party Content and do not guarantee the accuracy, integrity or quality of such Third Party Content. We are not responsible for the performance of, we do not endorse, and we are not responsible or liable for, any Third Party Content or any information or materials advertised in any Third Party Content. By using our Products, you may be exposed to content that is offensive, indecent, or objectionable. We are not responsible or liable, directly or indirectly, for any damage or loss caused to you by your use of or reliance on any goods, services, or information available on or through any third party service or Third Party Content. It is your responsibility to evaluate the information, opinion, advice, or other content available on and through our Products.
Proprietary Rights
John Snow Labs will not obtain any rights under this EULA from you (or your licensors) to your content.
The Products, including software, is and remains the exclusive property of John Snow Labs and its licensors. Except for the access and use rights expressly set forth in this EULA, no license or other rights in or to the Products or John Snow Labs trademark(s) and other intellectual property rights therein, are granted to you, and all such licenses and rights are expressly reserved. You will not remove, alter, or obscure any proprietary notices (including copyright and trademark notices) on any portion of our Products or any Content.
Trademarks
“John Snow Labs,” the John Snow Labs logo, and any other product, business or service name or slogan, whether registered or pending, displayed on our Products are trademarks of John Snow Labs, Inc. or its suppliers or licensors, and may not be copied, imitated or used, in whole or in part, without the prior written permission of John Snow Labs or the applicable trademark holder. You may not use any metatags or any other “hidden text” utilizing “John Snow Labs” or any other name, trademark or product, business or service name of John Snow Labs without our prior written permission. In addition, the look and feel of our Products, including all page headers, custom graphics, button icons and scripts, is the service mark, trademark and/or trade dress of John Snow Labs and may not be copied, imitated or used, in whole or in part, without our prior written permission. All other trademarks, pending trademarks, registered trademarks, product names and company names or logos mentioned in our Products are the property of John Snow Labs Inc. and/or their respective owners. Reference to any products, services, processes or other information, by trade name, trademark, manufacturer, supplier, or otherwise does not constitute or imply endorsement, sponsorship, or recommendation thereof by us.
Disclaimer of Warranties
YOUR USE OF THE PRODUCTS IS AT YOUR SOLE RISK. THE PRODUCTS AND CONTENT EACH ARE PROVIDED ON AN “AS IS” AND “AS AVAILABLE” BASIS. WE AND OUR SUPPLIERS AND LICENSORS EXPRESSLY DISCLAIM ALL WARRANTIES OF ANY KIND, WHETHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NON-INFRINGEMENT. WE DO NOT GUARANTEE THE ACCURACY, COMPLETENESS, OR USEFULNESS OF THE PRODUCTS OR ANY CONTENT, AND YOU RELY ON THE PRODUCTS AND CONTENT AT YOUR OWN RISK. ANY MATERIAL THAT YOU ACCESS OR OBTAIN THROUGH OUR PRODUCTS IS DONE AT YOUR OWN DISCRETION AND RISK AND YOU WILL BE SOLELY RESPONSIBLE FOR ANY DAMAGE TO YOUR COMPUTER OR LOSS OF DATA THAT RESULTS FROM THE DOWNLOAD OF ANY MATERIAL THROUGH OUR PRODUCTS. NO ADVICE OR INFORMATION, WHETHER ORAL OR WRITTEN, OBTAINED BY YOU FROM US OR THROUGH OR FROM OUR PRODUCTS WILL CREATE ANY WARRANTY NOT EXPRESSLY STATED IN THIS EULA. SOME STATES MAY PROHIBIT A DISCLAIMER OF WARRANTIES AND YOU MAY HAVE OTHER RIGHTS THAT VARY FROM STATE TO STATE.
Limitation of Liability
WE AND OUR SUPPLIERS AND LICENSORS WILL NOT BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR EXEMPLARY DAMAGES, INCLUDING BUT NOT LIMITED TO, DAMAGES FOR LOSS OF PROFITS, GOODWILL, USE, DATA, OR OTHER INTANGIBLE LOSSES (EVEN IF WE HAVE BEEN ADVISED OF THE POSSIBILITY OF THESE DAMAGES), RESULTING FROM YOUR USE OF OUR PRODUCTS AND CONTENT. UNDER NO CIRCUMSTANCES WILL THE TOTAL LIABILITY OF US AND OUR SUPPLIERS AND LICENSORS OF ALL KINDS ARISING OUT OF OR RELATED TO YOUR USE OF THE PRODUCTS AND CONTENT (INCLUDING BUT NOT LIMITED TO WARRANTY CLAIMS), REGARDLESS OF THE FORUM AND REGARDLESS OF WHETHER ANY ACTION OR CLAIM IS BASED ON CONTRACT, TORT, OR OTHERWISE, EXCEED THE AMOUNTS, IF ANY, THAT YOU HAVE PAID FOR YOUR USE OF THE PRODUCTS AND CONTENT. BECAUSE SOME STATES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF LIABILITY FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES, THE ABOVE LIMITATION MAY NOT APPLY TO YOU.
Indemnity
To the full extent permitted by applicable law, you shall defend, indemnify and hold harmless John Snow Labs, its affiliates and its licensors, and each of their respective employees, officers, directors, and representatives from and against any claims, damages, losses, liabilities, costs, and expenses (including reasonable attorney’s fees) arising out of or relating to any third party claim concerning: (a) your use of the Products; (b) breach of this EULA or violation of applicable law by you; (c) any content or the combination of such content with other software, content or processes, including any claim involving alleged infringement or misappropriation of third-party rights by such content or combination; or (d) breach of any obligation or duty you owe to a third party.
Legal Notices
Enforcement of this EULA will be governed by the laws of the State of Delaware, excluding its conflict and choice of law principles. The exclusive jurisdiction and venue for any claims arising out of or related to this EULA or your use of the Products will lie in the state and federal courts located in Sussex County, within the State of Delaware, and you irrevocably agree to submit to the jurisdiction of such courts. Our failure to enforce any right or provision in this EULA will not constitute a waiver of such right or provision unless acknowledged and agreed by us in writing. In the event that a court of competent jurisdiction finds any provision of this EULA to be illegal, invalid, or unenforceable, the remaining provisions will remain in full force and effect.
Notifications
We may use your contact information to notify you if we have any legitimate interest or if we need to notify you on any important information related to your use of Products. We will not send you newsletters unless you expressly consented to such notifications.
Contacting Us
If you have any questions or concerns about our Products or this EULA, you may contact us by email at support@JohnSnowLabs.com.
The Medical Product Safety Network dataset involves the reporting of problems with medical products from a network of approximately 300 hospitals, nursing homes and home health facilities around the United States.
MedSun sites work collaboratively with the FDA to assist in detecting, understanding, and sharing information concerning the safety of medical products. MedSun utilizes a secure, online system for reporting problems with the use of medical devices. MedSun plays a critical role in FDA’s postmarket surveillance efforts.
The primary goal for MedSun is to work collaboratively with the clinical community to identify, understand, and solve problems with the use of medical devices.
The Safe Medical Devices Act (SMDA) defines ‘user facilities’ as hospitals, nursing homes, and outpatient treatment and diagnostic centers. They are required to report medical device problems that result in serious illness, injury, or death. MedSun participants are also highly encouraged to voluntarily report problems with devices, such as ‘close-calls,’ potential for harm, and other safety concerns. By monitoring reports about problems and concerns before a more serious event occurs, FDA, manufacturers, and clinicians work together proactively to prevent serious injuries and death.
About this Dataset
Data Info
Date Created
2002
Last Modified
2025-12-30
Version
2025-12-30
Update Frequency
Daily
Temporal Coverage
2006-03-24 to 2025-12-30
Spatial Coverage
United States
Source
John Snow Labs; U.S. Food and Drug Administration (FDA);
MedSun Adverse Events Reports, MD Medical Product Safety Network, Medical Devices Safety Network
Data Fields
Name
Description
Type
Constraints
Device_Brand
The brand of medical device
string
-
Device_Manufacturer
Device manufacturer name
string
-
Device_Type
The type of medical device
string
-
Device_Problem
Problem associated with the device
string
-
Date_Report
The Date report
date
required : 1
Event_Description
The Event description
string
-
Data Preview
Device Brand
Device Manufacturer
Device Type
Device Problem
Date Report
Event Description
28 cm 12.5F dual lumen pheresis catheter
Medical Components Inc.
CATHETER SUBCLAVIAN
Death
2025-12-30
RN was removing 28 cm 12.5F Medcomp dual lumen pheresis catheter and during the removal - gentle tug on catheter and catheter snapped apart right at insertion site. Dressed with gauze and subsequently - patient became diaphoretic and unresponsive - breathing spontaneously. Coded and expired a few hrs later.
After added flex - it was apparent that the device was already underneath the tricuspid valve in the anteroseptal commissure. At this point - we had not advanced the clip delivery system at all. It became clear that they would not have been enough height above the tricuspid valve for us to successfully perform the procedure. We tried to retrieve the system. The system appeared to be caught underneath the tricuspid valve apparatus. With some retraction of the guide catheter - we were able to retrieve the device into the right atrium. We then tried to re-sheath the tricuspid clip device into the guide catheter and pulled the system into the IVC [inferior vena cava]. As soon as we retracted the device into the IVC - there was a new large pericardial effusion resulting in pericardial tamponade. The patient had hemodynamic compromise at that point. We performed emergent pericardiocentesis. There continue to be ongoing extravasation of blood - and she continued to become hemodynamically unstable. We called cardiac surgery for consultation. Doctor made the decision to open the patient to try identifying and repair the injury. With ongoing CPR - emergent sternotomy was performed. Cardiac exploration showed the location of tear to be in the IVC. The Tri clip guide catheter was removed - and the device was exchanged with a 22 French dry seal. A 20 French sheath was inserted in the left femoral vein. Unfortunately - the patient continued to bleed and was intravascularly volume depleted. Massive transfusion protocol was given via bifemoral sheaths. Continuous cardiac massage was performed while Doctor was trying to repair the IVC injury. A total of 45 minutes of attempt to resuscitate and control the bleeding were performed. However - the patient never regained a pulse and was ultimately pronounced dead at approximately 2 PM.
Minor injury to the patient or health care provider;Potential harm to a health care provider
2025-12-11
Multiple reports throughout [redacted]-multiple facilities reported in regard to Medline Gloves. See below reports associated with poor quality: Fusing - clumped together - stuck together - breaks - rips - tears - holes.... -I had gloves tear when trying to open them and then when trying to put them on. They are from BoSMA Enterprises-Medline. Precision Touch Ice. Size Large. -Gloves are coming out of box with cuffs fused together - ripped - tearing. Housekeeping personnel and some nursing personnel reported gloves disintegrating while wearing and using cleaning supplies. - Bosma enterprise gloves size medium multiple torn gloves directly out of boxes. Gloves rip easily upon donning. - New brand of gloves to mitigate past brand's deficiencies. - This brand of gloves is not reliable PPE [personal protective equipment]. -I have applied the new gloves size small all day today in several rooms. Every glove I initially put on ripped. I had to go through 1-3 pairs before I got one that did not rip. They are stuffed in the boxes so tight that when you pull a glove out they are sticking together. When you pull the gloves apart to put your hand in they rip. gloves with holes. -New gloves easily rip and very thin. Delayed care due to constantly pulling new gloves because they are all sticking to each other and then rips or the edge of the gloves fall apart - AND poor quality as I slide my hand in - it rips. Risk for fluid contamination to staff. -BOSMA Enterprises precision touch ice gloves are poor quality - torn at wrist -Gloves are unusable. Huge tears in gloves as they are coming out of the box. -Issue with new gloves: Throughout tour multiple pairs of gloves tore upon attempts to separate at wrist - where the opening should be. Many gloves appear to be stuck/melted/fused together at the wrist end. Also - multiple gloves tore with attempt to don. These gloves are brittle and the glove boxes are packed so tight initially - it is extremely difficult to remove the first 10-20 pairs without damaging the box or the gloves themselves. -The gloves provided are not OSHA [Occupational Safety and Health Administration] standard. The gloves break during donning and during DIRECT patient care where fluids are being delt with. -Every shift I have worked since we began using the new gloves - I have had multiple in a row tear immediately while putting them on. EVERY SINGLE SHIFT. Was going to patient care and gloved up before entering. Upon wearing the gloves noticed two holes at the tip on the third and 4th digit. This was on a medsurg inpatient unit. These are non-expired. Some of these have large holes before using it. -Please note that many of these boxes of gloves in all sizes have had MANY issues. The majority of the gloves in the box are thrown away because they are unusable. They have tears out of the box - they are missing the cuff - fingers - they have no opening to even put your hand in - they are stuck together and cannot be opened. They tear very easily which puts medical staff at risk of being exposed to bodily fluids. Major safety concern and delay in care trying to find a glove that is actually usable. Slows down workflow. The purple Bosma were great - the light blue were also awful - however these darker Medline precision ice have been the worst. -During surgery - sterile gloves tore without impetus. A new pair was handed to the field. These also tore when attempting to put them on via sterile technique. This occurred with the Scrub RN - all three surgeons. Medline Sensicare PI REF MSG9080 Lot#5024581480-2. This placed the patient at risk for SSI [surgical site infection] due to breaks in sterility. -Precision touch ice gloves size small - ripped when attempting to put on. LOT 4518686929SM. supply came and collected the box of gloves that are bad. She brought me a new lot#. Unfortunately - these are bad as well. I will attach [redacted] information of the gloves out of the new lot. Lot # 4518686929SM. PrecisionTouch Ice glove - Quality issue. Gloves are adhered shut. -Difficult to separate. -Adhered together - time consuming to open each glove. -Rip easily whiling donning Staff attempted to use medium gloves but 7 gloves pulled were defective. Each glove that was pulled wouldn't open or was torn. Medium -Gloves were ripped in two separate Veteran rooms while staff were completing nursing cares. -staff reported pulling out at least 5 ripped gloves in various Veteran rooms when completing Veteran cares. -staff noted another ripped glove when taking a pair of gloves out of a box in a Veteran room. -Ripped gloves pose an infection control risk. -Gloves in the endoscopy labs now torn DURING a colonoscopy three times this week. Every staff member is having this problem. This occurred on one occasion with a patient who has a chronic hepatitis virus. These gloves are made very poorly and we often go through 4+ before we find a pair that does not rip immediately. -Attempted to retrieve 2 Medium size gloves from the glove box for donning to clean an exam room. Very difficult to pull the gloves from the box due to being very compacted. When I pulled the first glove from the box - it ripped. I pulled out the second glove and when donning it - it ripped. I then gently pulled 2 more gloves and gently put them on to avoid ripping. I did have to un-wrinkle both gloves prior to applying them. Here is a list of some of the reports we received that were defective: 1-Medline Precision Touch Ice powder free nitrile exam gloves Size Small 73-20501 - Lot: 4518686926SM 2025-09-01 ESMO5252460 2-Medline Precision Touch gloves - Lot: 4518686926sm - Lot: 4518686929SM - Lot: 4518686929sm - Lot: 4518686929sm - Lot: 451868629SM - Lot: 4518686929SM - Lot: 4518686929SM 3-Ref 73-20503 - Lot: 4518686929LG - 451868692LG - Lot: 4518686929SM - 4518686929SM 4-Ref 73-20502 Lot: 4518686929MD - 4518686929MD 5-Medline Sensicare PI REF MSG9080 Lot#5024581480-2 - LOT 4518686929SM - 4518686929MD ====================== Manufacturer response for Medline Precision Touch Ice powder free nitrile exam gloves - Precision Touch Ice powder free nitrile exam gloves (per site reporter) ====================== No improvements to products. They replaced with other products that were also defective and poor quality. ====================== Manufacturer response for Medline Sensicare PI - Medline Good Works Performance Pro Nitrile Gloves (per site reporter) ====================== Replaced with products also unusable and defective. ====================== Manufacturer response for Medline Gloves - Medline Precision Touch Ice glove (per site reporter) ====================== They replaced with other products as well that were defective.
OptiCross⢠6 HD
BOSTON SCIENTIFIC CORPORATION
Transducer ultrasonic diagnostic
Potential for patient harm
2025-12-08
stopped transmitting to screen -DID NOT RECIEVE DEFECTIVE PRODUCT IT WAS DISCARDED ====================== Manufacturer response for coronary imaging catheter - OPTICROSS 6 HD (per site reporter) ======================
FARAWAVEâ¢
BOSTON SCIENTIFIC CORPORATION
Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with
Potential for patient harm
2025-12-08
Farawave did not perform as expected. No Patient harm occurred another farawave was opened to complete the case. Vendor notified ====================== Manufacturer response for ablation catheter - Farawave Farapulse (per site reporter) ======================
Steripath Micro
Magnolia Medical Technologies Inc.
Set Administration Intravascular
Potential for patient harm;Potential harm to a health care provider
2025-12-08
S: Steripath device failed - tubing was damaged and blood leaked while cultures were being drawn. B: Pt ordered for blood cultures - site was prepped - vessels accessed - blood leaked from tubing. A: Product (Steripath Micro Ref 4010-23UT-EN Lot 114881854) was damaged and clinician did not notice until blood was flowing through the tubing. R: Determine if this is an isolated event. The product was shipped to the manufacturer for investigation. a letter from the manufacturer investigation is attached ====================== Manufacturer response for IV Tubing - (brand not provided) (per site reporter) ====================== emailed mfg [redacted] - shipped the product [redacted] via fedEx
PENTARAY NAV
Biosense Webster Inc
CATHETERINTRACARDIAC MAPPINGHIGH-DENSITY ARRAY
Potential for patient harm
2025-12-08
The signal from the mapping catheter stopped working after placed into the patient. The catheter was removed and replaced with no reported harm ====================== Manufacturer response for vascular mapping catheter - 7Fr PentaRay Nav Eco HighDensity Mapping Catheter - 2-6-2 Spacing - F-Curve (per site reporter) ======================
Broselow Tape version 3
SUNMED GROUP HOLDINGS LLC DBA AIRLIFE
Emergency Response Safety Kit
Potential for patient harm
2025-12-08
S [situation]: 2025 Version 3 Broselow Tape has been identified to include 2 incorrect medication dosages listed in the calculation legend. B [background]: Broselow Tape is a tool used in pediatric emergencies to help dose medications and select appropriately sized equipment. A new version was released in 2025. A [assessment]: It has been identified that there are 2 medications with incorrect dosages listed on the Calculated Basis portion of the tool affecting the listed Vecuronium and Flumazenil. The precalculated dosages are listed correctly in the color-coded portion. R [recommendation]: Notification of all key stakeholders and widespread awareness of issue - black out the incorrect information on all Version 3 Broselow Tapes in circulation at [redacted] - [redacted] - and [redacted] Health Center - and replacement with corrected Broselow Tape once it becomes available from the manufacturer. This is similar to the issue the Manufacturer reported in a bulletin about the previous version (Version 2) in May 2025. Supply Chain emailed the vendor rep multiple times in the past week to ask for an update and documentation about these errors and have not received any responses. ====================== Manufacturer response for medication calculation guidance document - Broselow Tape version 3 (per site reporter) ====================== several attempts to reach vendor without replies
EndoFLIP
Covidien LP
System Gastrointestinal Motility (Electrical)
Potential for patient harm
2025-12-05
TUBING WAS LEAKING SO PRESSURE SENSOR KEPT FAILING
Perclose ProGlideâ¢
ABBOTT VASCULAR INC.
DEVICE HEMOSTASIS VASCULAR
Not known;Potential for patient harm
2025-12-05
From Staff: Perclose devices were deployed for groin closure. 3 of the closure devices failed- the physician asked for a different lot number of the same closure device and the device deployed as normal. No harm was done to the patient. ? bad lot of perclose devices. Lot#5091541 Perclose Proglide REF#12673-03.
Demos
