BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2081580 · Received May 2, 2011

    Report

    Report Number
    2081580
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 2, 2011
    Manufacturer
    BARD
    Product Code
    KNX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE FOLEY CATHETER WAS PLACED AT THE BEGINNING OF THE RN'S SHIFT, WITH THE FOLEY DRAINAGE BAG. THE PRACTITIONER COULD DISTINCTLY SEE URINE WAS LEAKING FROM THE SEAL WHERE THE DRAINAGE TUBE WAS ATTACHED TO THE BAG. THEY REPLACED THE BAG AND THE REPLACEMENT BAG WORKED WITHOUT ANY PROBLEMS. OUR SISTER HOSPITAL HAS BEEN WORKING DIRECTLY WITH BARD AND FDA. I HAVE ALSO INFORMED THEM OF OUR ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * BARD FOLEY DRAINAGE BAGS KNX BARD UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES