BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX I.C.

    MDR report key: 2181149 · Received July 20, 2011

    Report

    Report Number
    2181149
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 20, 2011
    Manufacturer
    BARD
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE FOLEY CATHETER BAG WAS FOUND LEAKING. IT HAS A HOLE UNDER THE HARD PLASTIC URINE METER WHERE IT MEETS THE PLASTIC BAG. THIS IS AN ONGOING ISSUE THAT BARD IS WELL AWARE OF. THE REP WAS HERE YESTERDAY AND "WE ARE THE ONLY FACILITY IN THE COUNTRY " HAVING THIS ISSUE. THE PLAN IS TO REPLACE THE DEVICE WITH THE NEWEST BARD MODEL IC TRAY IN SEPTEMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARDEX I.C. TEMPERATURE SENSING IC 350ML URINE METER FOLEY TRAY KOD BARD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR