BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD 350MM URINE METER DRAINAGE BAG

    MDR report key: 89655 · Received May 9, 1997

    Report

    Report Number
    MW1011276
    Event Type
    Malfunction
    Date Received
    May 9, 1997
    Date of Event
    May 7, 1997
    Report Date
    May 8, 1997
    Manufacturer
    BARD UROLOGICAL DIVISION C.R. BARD, INC.
    Product Code
    KNX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WON'T DRAIN, URINE STAYS IN DRAINAGE TUBING SO BLADDER OVERFILLS. HAVE TO MANIPULATE HOW THE TUBING LAYS ON THE BED TO GET IT TO DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD 350MM URINE METER DRAINAGE BAG URINARY CATHETER DRAINAGE SYSTEM KNX BARD UROLOGICAL DIVISION C.R. BARD, INC. * 76 BH2898, 76 AH 2132

    Patients

    Seq Age Sex Outcome Treatment
    1 *