BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C.R. BARD, INC.

    MDR report key: 241050 · Received September 16, 1999

    Report

    Report Number
    MW1017185
    Event Type
    Malfunction
    Date Received
    September 16, 1999
    Date of Event
    September 4, 1999
    Report Date
    September 7, 1999
    Manufacturer
    C.R. BARD, INC.
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BALLOON FOLEY CATHETER WOULDN'T DEFLATE. ATTEMPTED WIRE INSERTION THROUGH BALLOON PORT AND CUTTING BALLOON PORT, UNABLE TO DEFLATE. UROLOGIST WAS CALLED TO COME INTO THE ER. HE INSERTED GUIDEWIRE AND REMOVED THE FOLEY. PT GIVEN DEMEROL FOR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C.R. BARD, INC. 16 FR FOLEY CATHETER W/5CC BALLOON KOD C.R. BARD, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other