BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD FOLEY CATHETER WITH URIMETER

    MDR report key: 1923323 · Received December 3, 2010

    Report

    Report Number
    1923323
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 21, 2010
    Report Date
    December 3, 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 FOLEY BAG WAS FOUND TO BE LEAKING ONTO THE FLOOR. THIS IS AN ONGOING ISSUE WITH THIS PRODUCT. WE ARE AGAIN REPORTING THE DEFECT. THE PRODUCT DEVELOPS A LEAK WHERE THE URIMETER CONNECTS TO THE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD FOLEY CATHETER WITH URIMETER FOLEY CATHETER BAG WITH URIMETER ATTACHED KNX BARD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR