Others titles

  • MedSun Adverse Events Reports
  • MD Medical Product Safety Network
  • Medical Devices Safety Network

Keywords

  • Medical Product Safety
  • Adverse Event Reporting Program
  • MedSun
  • 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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Description

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

2020-11-04

Version

2020-11-04

Update Frequency

Daily

Temporal Coverage

2006-03-24 to 2020-11-04

Spatial Coverage

United States

Source

John Snow Labs; U.S. Food and Drug Administration (FDA);

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

Medical Product Safety, Adverse Event Reporting Program, MedSun, MD Safety, MD Reporting

Other Titles

MedSun Adverse Events Reports, MD Medical Product Safety Network, Medical Devices Safety Network

Data Fields

Name Description Type Constraints
Device_BrandThe brand of medical devicestring-
Device_ManufacturerDevice manufacturer namestring-
Device_TypeThe type of medical devicestring-
Device_ProblemProblem associated with the devicestring-
Date_ReportThe Date reportdaterequired : 1
Event_DescriptionThe Event descriptionstring-

Data Preview

Device BrandDevice ManufacturerDevice TypeDevice ProblemDate ReportEvent Description
EXPEDIUM SPINE SYSTEM BALL TIP FEELERDEPUY SPINE LLCPROBEPotential for patient harm2021-09-15The patient was undergoing a laminectomy with spinal fusion. During palpation of the right L5 pedicle - the ball point probe broke and could not be safely removed. The surgeon believed that the risk of morbidity with attempted removal - outweighed any benefit. The broken portion (approximately 2.5cms) was left and disclosed to the patient.
VASCBANDTELEFLEX INCORPORATEDCLAMP VASCULARPotential for patient harm2021-09-15Patient with history of Coronary artery disease (CAD) and Hypertension (HTN) presented with new onset of chest pain. When preparing for heart cath - the package of the Teleflex VASCBAND was open and a hard plastic rectangle piece fell on the floor. The product was not used on the patient and another was used successfully. The hard plastic rectangle piece was not secured on the band as it usually is. All packages of the hemostat vascular band come in boxes- boxes are stored on a shelf in stock room. Packages are removed from box and placed in drawers of the procedure rooms.
Wayne Pneumothorax Catheter Set and TrayCOOK INCORPORATEDCATHETER AND TIP SUCTIONPotential for patient harm2021-09-15Middle-aged male patient developed pleural effusion and pneumothorax requiring bedside placement of a left-sided pigtail pleural catheter using modified Seldinger technique. The inserting provider reportedly encountered slight resistance when removing the guidewire after the catheter was advanced - but visually inspected the wire upon removal and believed it to be intact. A chest x-ray taken immediately post-insertion appeared to be negative for a retained foreign body. Serial daily chest x-rays were obtained - and also appeared negative for a retained foreign body until approx. 4 days post-insertion - when the reading was suspicious for a retained wire. The pleural catheter was removed - and a retained guidewire fragment was noted. The catheter was easily removed but the guidewire fragment initially remained lodged in the patient's chest wall. Ultimately - the guidewire fragment was removed without harm to the patient and a subsequent chest x-ray confirmed there was no additional guidewire remaining. A post-event review developed the following recommendations: (1) Update IFUs to denote risk for guidewire fracture - particular when resistance is met during guidewire removal; (2) Submit FDA MedSun report to raise awareness of risk for this device complication and that a retained guidewire fragment may not be visible on initial chest x-rays.
COR-KNOT MINILSI Solutions Inc.Instrument Ligature Passing And Knot TyingNot applicable2021-09-15The device cut the suture without firing the handle.
3M Aura Particulate Respirator 9205+ N953M COMPANYRespirator surgicalNot known;Potential harm to a health care provider2021-09-15It was reported on September 2021 - that on one of our nursing units there are defective 9205 N95 --the bottom of the mask is missing an entire layer of fabric. Team members reported that these defective masks have been in use since last week. These defective masks would not have a good seal - but staff may not have recognized this. Float Pool and Agency nurses filling in on this nursing unit may not have routinely used N95 masks and may not have been aware that the masks were defective. All of the defective masks have the same lot number and no masks were found that were defective and had a different lot number. Injury: At this time - unknown. There is potential exposure. It is believed at this time that these defective masks were only stocked on the one nursing unit. Actions taken: Investigation has begun into this as a potential PPE breach that impacts multiple staff groups. All unit and leaders have been asked to remind their staff to perform an N95 fit check (which is standard practice) and to pull and report any masks that do not give a good seal. All of the 9205 N95 masks with the affected lot number have been pulled from inventory. It was found that not all of the masks with this lot number were defective. However - all were pulled and isolated. All areas with the 9205 N95 masks had their stock switched out with product with new lot numbers.
Olympic Smart ScaleNATUS MEDICAL INCORPORATEDSCALE PATIENTNot known;Potential for patient harm2021-09-14A second Natus/Olympus Smart Scale 70 within two months - who's AC adapter clip broke off. While this is caused by user error (moving scale before disconnecting) it is poorly made and should not break so easy!
PowerPICC CatheterBard Access Systems Inc.Catheterintravasculartherapeuticlong-term greater than 30 daysPotential for patient harm2021-09-14Patient had Peripherally-Inserted Central Venous Catheter (PICC) line inserted by experienced and trained RN. Difficult placement due to patient's traumatic injuries. Post placement a Chest X-ray (CXR) was done which showed metallic wire over the right axilla. The patient was taken to interventional radiology where he had an ultrasound guided removal of the foreign body. It was in the right cephalic vein and a portion was removed using balloon angioplasty. 2 separate small 3 mm metallic fragments were identified on fluoroscopy but were not clearly intravascular or retrievable. The removed portions were retained as well as the insertion kit and PICC line.
Bard DigniShield Stool Management SystemC. R. Bard Inc.TUBES GASTROINTESTINAL (AND ACCESSORIES)Potential for patient harm2021-09-14Pilot balloon leaking.
ARROWTELEFLEX INCORPORATEDCATHETER CONDUCTION ANESTHETICPotential for patient harm2021-09-13Large leak noted in epidural catheter proximal to snap-lock adapter - after test dose administered. Catheter removed w/o injury to pt. Another kit opened and successfully administered epidural w/o difficulty.
Steerable Introducer Sheath 8.5F Medium CurlFREUDENBERG MEDICAL LLCIntroducer CatheterPotential for patient harm2021-09-13Catheter tip crimping on itself upon femoral access insertion.