BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD TOUCHLESS MALE CATHETER KIT

    MDR report key: 192786 · Received October 22, 1998

    Report

    Report Number
    MW1014783
    Event Type
    Malfunction
    Date Received
    October 22, 1998
    Date of Event
    September 1, 1998
    Report Date
    October 22, 1998
    Manufacturer
    C.R. BARD INC. UROLOGICAL DIVISION
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAS BEEN USING THESE DEVICES FOR THE PAST 11 YRS. IN THE LAST 2 MONTHS HE HAS NOTICED THAT AT LEAST 25% OF EACH CASE HAS BEEN UNDERSIZED RESULTING IN DIFFICULT INSERTION DUE TO KINKING AND COLLAPSING. WHEN RPTR ADDRESSED THE PROBLEM WITH THE MFR, THEIR RESPONSE, ACCORDING TO THE RPTR WAS "WE ARE ALLOWED TO HAVE A TWO SIZE VARIABILITY FROM THE SIZE LABELED ON THE PACKAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD TOUCHLESS MALE CATHETER KIT IN & OUT CATH 14FR KOD C.R. BARD INC. UROLOGICAL DIVISION NA 76F12677

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR