BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDIA

    MDR report key: 3934536 · Received July 10, 2014

    Report

    Report Number
    MW5037246
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BARD
    Product Code
    KOD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LEAKAGE OF FOLEY CATHETER BAG BIOHAZARD. I HAD PREVIOUSLY USED THE BARD LATEX - FREE URINARY DRAINAGE BAG WITHOUT PROBLEMS. BOUGHT THE BARDIA CLOSED SYSTEM URINARY DRAINAGE BAG AND IT LEAKED EVEN WITH THE PLASTIC VALVE CLOSED. REORDER NUMBER 802001 LOT NUMBER NGYD3918. PLEASE HAVE BARD REDESIGN THE CLOSURE SYSTEM USING THE SAME COMPONENTS AS THEIR BAG REF NO 154002. THAT SHOULD FIX THE PROBLEM. I THINK THEY USED INFERIOR COMPONENTS AND AS A RESULT HAD A LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402516 BARDIA NONE KOD BARD 802001 NGYD3918

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other BARD LATEX FREE URINARY DRAINAGE BAG REF #154002