BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C.R. BARD, INC.

    MDR report key: 809434 · Received January 25, 2007

    Report

    Report Number
    MW1041745
    Event Type
    Malfunction
    Date Received
    January 25, 2007
    Date of Event
    January 23, 2007
    Report Date
    January 25, 2007
    Manufacturer
    C.R. BARD, INC.
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BARD "LUBRICATH", FOLEY CATHETER, 12 FRENCH USED ON A MALE PATIENT. UPON DOCTOR'S ORDER FOR REMOVAL OF CATHETER, IT WAS DISCOVERED THAT THE FLUID-FILLED BULB ON THE CATHETER WOULD NOT DEFLATE. THE BULBS ON THESE CATHETERS ARE FILLED WITH 10ML STERILE SALINE PER MANUFACTURER'S INSTRUCTIONS. CATHETER COULD NOT BE REMOVED. THEREFORE, PHYSICIAN HAD TO CUT THE CATHETER IN ORDER TO REMOVE IT FROM THE PATIENT'S BLADDER. THE CATHETER WAS SUBMITTED THE DAY OF THE INCIDENT. THIS PARTICULAR CATHETER HAD THE FOLLOWING NUMBERS DISPLAYED ON IT: 0168L 12, NT531.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C.R. BARD, INC. LUBRICATH, FOLEY CATHETER KOD C.R. BARD, INC. * 0168L 12, NT531

    Patients

    Seq Age Sex Outcome Treatment
    1 *