BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAY, FOLEY, BARDEX I.C. TEMPERATURE SENSING INFECTION CONTR

    MDR report key: 2181087 · Received July 14, 2011

    Report

    Report Number
    2181087
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 14, 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

    THE FOLEY CATHETER BAG WAS LEAKING AT SITE WHERE THE WHITE EMPTYING PORT ATTACHES TO THE BAG. THE CATHETER WAS CHANGED PER POLICY. THIS HAS BEEN AN ONGOING ISSUE WITH THIS DEVICE. WE THOUGHT THE ORIGINAL FAILURES WERE DUE TO A PROCESS WE HAD ADDED HERE. THESE NEW LEAKS ARE UNRELATED AS THAT PROCESS WAS STOPPED IN MARCH. WE WILL BE GOING TO A NEW BARD T-S PRODUCT SOON. WE WILL CONTINUE TO REPORT ANY DEVICE FAILURES, HOWEVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAY, FOLEY, BARDEX I.C. TEMPERATURE SENSING INFECTION CONTR BARDEX I.C. TEMPERATURE SENSING INFECTION CONTROL 350 ML URI KOD BARD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR NONE THAT APPLY