BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIPURPOSE CATHETER

    MDR report key: 1639118 · Received March 19, 2010

    Report

    Report Number
    MW5015255
    Event Type
    Malfunction
    Date Received
    March 19, 2010
    Date of Event
    March 18, 2010
    Report Date
    March 19, 2010
    Manufacturer
    COOK, INC.
    Product Code
    GBX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN PERFORMED ROUTINE TUBE CHANGE ON THIS OUTPATIENT. WHILE PT WAS DRESSING, SHE FOUND TUBE TO BE LEAKING URINE. WE FOUND TUBE TO BE LEAKING URINE ALSO. RETURNED PT TO PROCEDURE ROOM AND PERFORMED TUBE CHANGE AGAIN. DEFECTIVE TUBE IS BEING SENT BACK TO MFR (COOK, INC.) FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIPURPOSE CATHETER GBX COOK, INC. REF# G10435 2456926

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR