BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITANIUM LIGATION CLIP MEDIUM BLUE

    MDR report key: 16353102 · Received February 9, 2023

    Report

    Report Number
    MW5114852
    Event Type
    Malfunction
    Date Received
    February 9, 2023
    Date of Event
    January 26, 2023
    Report Date
    February 7, 2023
    Manufacturer
    TELEFLEX LLC (NADC)
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A GENERAL SUMMARY IS THAT THE PHYSICIANS FEEL THIS IN AN INFERIOR PRODUCT. THE CLIPS FALL OUT OF THE APPLIER WHEN TRYING TO HAND IT TO THE PHYSICIAN, THEY CAN SEVER THE VESSEL, AND THE CARTRIDGE THAT THE CLIPS SIT IN WILL SOMETIMES CHIP AND COME OUT WITH THE CLIP. IN THIS INSTANCE, THE PATIENT'S VESSEL WAS LACERATED REQUIRING REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1607376 TITANIUM LIGATION CLIP MEDIUM BLUE CLIP, IMPLANTABLE FZP TELEFLEX LLC (NADC) 40425S

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Other