BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1974552 · Received January 21, 2011

    Report

    Report Number
    1974552
    Event Type
    Malfunction
    Date Received
    January 21, 2011
    Report Date
    January 21, 2011
    Manufacturer
    BARD
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THIS REPORT FOLLOWS UP ON OUR PREVIOUS REPORTS ABOUT THIS ISSUE.CURRENTLY I HAVE TEN MORE PRODUCTS WITH THIS LEAKING. I HAVE RETURNED THEM TO BARD. WE ARE WORKING WITH THEM TO TRY AND INDENTIFY THE SOURCE. WE HAVE NOTED THAT THIS FACILITY ADDS AN EXTRA LAYERING OF PACKAGING TO THE ORIGINAL BARD KIT. WE DO THIS TO INCLUDE PRODUCTS THAT OUR CATHETER INFECTION TEAM FELT WAS NEEDED TO DECREASE THE RATES OF URINARY TRACT INFECTIONS (UTI)'S. THE ADDED PRODUCTS ARE PUT IN A LARGE PLASTIC BAG THEN THE STERILE BARD KIT IS ALSO PUT IN THE BAG AND THIS BAG IS THEN RESEALED BY (B) (6) AND THEN SENT TO (B) (6). WE ARE THE ONLY SITE DOING THIS EXTRA PROCESS. ALL EVENTS OCCUR IN THE CRITICAL CARE UNITS. THE EVENTS INVOLVE BOTH TEMPERATURE SENSING AND NON TEMP SENSING FOLEY KITS. WE ARE CURRENTLY STILL TRYING TO ASCERTAIN A SOLUTION. THE MANUFACTURER'S RESPONSE FOR BARD COMPLETE CATHETER KITS IS WE ARE WORKING TO RESOLVE THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * BARD COMPLETE CATHETER KITS KOD BARD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NONE APPLICABLE