BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEV GN BR 0 TC-43/HR26 2N 36"

    MDR report key: 12225498 · Received July 26, 2021

    Report

    Report Number
    3004365956-2021-00245
    Event Type
    Malfunction
    Date Received
    July 26, 2021
    Date of Event
    May 18, 2021
    Report Date
    July 12, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAT
    UDI-DI
    14026704603876
    PMA / PMN Number
    K021019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO ISSUES OR DISCREPANCIES WERE FOUND IN THE DEVICE HISTORY RECORD OF PRODUCT CODE 833-114 / BATCH 74F1902783 THAT CAN BE RELATED TO THE FAILURE MODE REPORTED. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    DURING SACROSPINOUS FIXATION THE BULLET AT THE TIP OF THE SUTURE GOT STUCK IN THE CAPIO SLIM WHILE PUSHING THE HANDLE OF THE CAPIO. THIS EVENT HAPPENED SEVERAL TIMES AND FINALLY, SHE HAD TO USE ANOTHER CAPIO SLIM TO SOLVE THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121987 TEV GN BR 0 TC-43/HR26 2N 36" SUTURE, NONABSORBABLE, SYNTHE GAT TELEFLEX MEDICAL IPN000859 74F1902783 14026704603876

    Patients

    Seq Age Sex Outcome Treatment
    1