BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX CATHETER SYSTEM DRAINAGE BAG

    MDR report key: 1749636 · Received June 22, 2010

    Report

    Report Number
    1749636
    Event Type
    Malfunction
    Date Received
    June 22, 2010
    Date of Event
    June 22, 2010
    Report Date
    June 22, 2010
    Manufacturer
    BARD
    Product Code
    KNX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE URINE BAG WAS FOUND TO BE TORN WITH URINE LEAKING ALL OVER THE FLOOR. THIS IS THE 4TH TIME THIS MONTH THAT OUR NURSES HAVE FOUND THESE BAGS TO BE LEAKING. THIS ONE TORE UNDER THE URIMETER, NEAR THE OPENING TO TIP THE URINE INTO THE BAG. IT IS A POTENTIAL INFECTION RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARDEX CATHETER SYSTEM DRAINAGE BAG COLLECTOR, URINE, CATHETER SYSTEM WITH DRAINAGE BAG KNX BARD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR