- MedSun Adverse Events Reports
- MD Medical Product Safety Network
- Medical Devices Safety Network
- Medical Product Safety
- Adverse Event Reporting Program
- MD Safety
- MD Reporting
Medical Product Safety Network
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).
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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
2006-03-24 to 2022-09-21
John Snow Labs; U.S. Food and Drug Administration (FDA);
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Medical Product Safety, Adverse Event Reporting Program, MedSun, MD Safety, MD Reporting
MedSun Adverse Events Reports, MD Medical Product Safety Network, Medical Devices Safety Network
|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||-|
|Device Brand||Device Manufacturer||Device Type||Device Problem||Date Report||Event Description|
|BIOFLO VORTEX PORT||ANGIODYNAMICS INC||PORT & CATHETER IMPLANTED SUBCUTANEOUS INTRAVASCULAR||Potential for patient harm||2022-09-21||Provider inserting an Angio Dynamic SmartPort Low Profile Port with Vortex Technology. During insertion - provider reported the wire became stuck inside the introducer.|
|Reciprocating Blade Heavy Duty Long Offset (77.6 x 0.77 x 11.2mm)||STRYKER CORPORATION||BLADE SAW GENERAL & PLASTIC SURGERY SURGICAL||Potential for patient harm||2022-09-20||END OF STRYKER SAW BLADE 0277-096-325 (LOT:22031017 - EXP: 02/01/2027) BROKE INSIDE SYSTEM 8. NO PIECE OF SAW BROKE OFF INTO PATIENT. BLADE WAS REMOVED AND BROKEN PIECE STUCK INSIDE SYSTEM 8 HANDPIECE. CHARGE RN NOTIFIED - MANAGER NOTIFIED. NEW SYSTEM 8 AND NEW SAW BLADE OPENED AND USED WITHOUT FURTHER ISSUE. NO X-RAY VISUALIZATION REQUIRED PER Manager.|
|Perceval Sutureless Aortic Heart Valve||Livanova Canada Corp||heart-valve non-allograft tissue||Death||2022-09-20||Patient (pt) admitted with NSTEMI (Non-ST-elevation myocardial infarction) - aortic stenosis. Was taken to OR (operating room) by doctor. There were issues in OR with the aortic valve: requiring opening aorta multiple times and ultimately replacing valve twice. Pt had long pump time and required multiple blood products. Impella was placed and chest left open. Initial valve used was a sutureless valve that we have not used here. However - surgeon expressed that he was comfortable with valve. It was never determined why valve was nonfunctioning. Case should be reviewed. PI (patient identifier) Note: Person that entered SIR entered under incorrect visit.|
|Bard Nasogastric Sump Tube||TUBE NASOGASTRIC||Not applicable;Potential for patient harm||2022-09-20||Hole found in Nasogastric Tube (NGT) shortly after placement. Hole located in the tubing were the blue tubing attaches to the clear plastic. RN discovered gastric contents leaking from tubing.|
|Coblation||SMITH AND NEPHEW INC.||ELECTROSURGICAL CUTTING COAGULATION ACCESSORIES||Not known;Potential for patient harm||2022-09-20||Device plugged into coblater and will not work. Device unplugged - coblater turned off and then on again. Device still would not work. New device opened and plugged in and worked.|
|Spectrum IQ||BAXTER INTERNATIONAL INC.||Pump Infusion||Serious injury||2022-09-20||Baxter pump failed to alarm for an upstream occlusion for a kinked IV tubing. This patient is on a pressor - and this is the medication that is a part of this situation. The patient's BP started to drop suddenly - MD notified immediately - this RN having to titrate pressor up - however this entire time the IV tubing had a small barely noticeable kink that the IV pump probably should have alarmed for an upstream occlusion. Per clinical engineering: Pump was programmed for norepinephrine on [redacted date] at 17:07 in the logs (1:07pm) and there were a couple upstream occlusions over the next few days without the tubing being reloaded - which could have caused the sensor to be reset. The pump passed all the usual verification tests.|
|Concerto Detachable Coil System Nylon||MICRO THERAPEUTICS INC. DBA EV3||Device Vascular for Promoting Embolization||Potential for patient harm||2022-09-20||Doctor was attempting to deploy an embolization coil during a Hepatic Artery Radioembolization Planning exam. As the Coil was being advanced through the microcatheter - there was significant resistance. The coil was re-sheathed and the microcatheter was exchanged for a new microcatheter. Doctor then attempted to advance the coil - again meeting with resistance. The coil could not be advanced through the microcatheter and into the patient. The coil was removed/re-sheathed and sent to manufacturer as defective.|
|Resolution 360 clip||BOSTON SCIENTIFIC CORPORATION||Hemostatic metal clip for the GI tract||Potential for patient harm||2022-09-20||1. The Resolution 360 clip package labeled with a 1 in the top right corner deployed prematurely when device was opened. 2. The Resolution 360 clip package labeled with a 2 in the top right corner also deployed prematurely - but when device was closed.|
|Medline gloves||Medline Industries Inc.||Non-Powdered Patient Examination Glove||Not applicable||2022-09-19||Gloves in clinic - many are glued together - and some have holes in them. Unfortunately - they were not in the original box - so we don't know exactly what box they came out of/size/etc.|
|Neonatal flow sensor insert||Draegerwerk AG & Co. KGaA||Transducer Gas Flow||Not applicable||2022-09-19||When the neonatal flow sensor was removed from the sterile processing package and placed in line with vent for testing - the neonatal flow sensor would not work. The knobs on the insert were bent in slightly and the flow sensor repeatedly failed calibration. It was unseated and placed in the housing several times - failing calibration every time. It is felt that the processing is causing the plastic to harden and the knobs to bend or break more easily when being removed or placed in the flowsensor. This directly affects the chip inside the flow sensor. This has happened 9 times in 15 processings so a failure rate greater than 50%.|