BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX I.C. COMPLETE CARE

    MDR report key: 2220377 · Received August 11, 2011

    Report

    Report Number
    2220377
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BARD
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    URINE WAS NOTED DRIPPING ON THE FLOOR UNDER THE FOLEY BAG. THE SOFT PLASTIC WAS TORN ON THE BAG WHERE THE RIGID PLASTIC OF URIMETER MEETS THE BAG. THIS OCCURRED JUST EXACTLY WHERE ALL THE OTHER FOLEY BAGS HAVE TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARDEX I.C. COMPLETE CARE FOLEY CATHETER BAG FROM KIT WITH FOLEY ATTACHED-NON-TEMP SEN KOD BARD 04111V *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NONE KNOWN