BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD IC URINE METER BAG

    MDR report key: 1871420 · Received September 22, 2010

    Report

    Report Number
    1871420
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    September 11, 2010
    Report Date
    September 22, 2010
    Manufacturer
    CR BARD
    Product Code
    KNX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE NURSE WENT TO EMPTY THE UROMETER AND NOTICED THE FLOOR WAS WET SURROUNDING THE FOLEY URINE BAG. UPON FUTHER INSPECTION BAG WAS FOUND TO HAVE A LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD IC URINE METER BAG URINE METER DRAINAGE BAG KNX CR BARD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR NONE KNOWN