BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY BALLOON DILATOR 8MM3CM

    MDR report key: 10149061 · Received June 12, 2020

    Report

    Report Number
    1320894-2020-00259
    Event Type
    Malfunction
    Date Received
    June 12, 2020
    Report Date
    July 21, 2020
    Manufacturer
    CONMED CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K920361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE 000349 IN UNOPENED ORIGINAL PACKAGING. LOT NUMBER WAS VERIFIED. PERFORMED A VISUAL INSPECTION, THERE WERE NO OBVIOUS SIGNS OF ABNORMALITIES OR DEFECTS. PERFORMED A FUNCTIONAL INSPECTION, THE DEVICES WERE DYE LEAK TESTED, WHICH INDICATED THAT THE PACKAGING DID NOT HAVE AN INSUFFICIENT HEAT SEAL. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WERE FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN 1 COMPLAINT REGARDING 1 DEVICE FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THE SAME TIME FRAME 771 DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED, THE RATE OF FAILURE WOULD BE .001 PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING; EXAMINE EACH DILATOR PRIOR TO USE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE DISTRIBUTOR IN (B)(4) REJECTED 000349, BILIARY BALLOON DILATOR 8MM3CM, DUE TO AN "INSUFFICIENT HEAT SEAL". IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INCOMING INSPECTION PRIOR TO DISTRIBUTION TO AN END-USER. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612843 BILIARY BALLOON DILATOR 8MM3CM BILIARY DILATOR FGE CONMED CORPORATION 201903181

    Patients

    Seq Age Sex Outcome Treatment
    1