BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C.R. BARD INC.

    MDR report key: 212374 · Received February 23, 1999

    Report

    Report Number
    MW1015773
    Event Type
    Malfunction
    Date Received
    February 23, 1999
    Date of Event
    February 11, 1999
    Report Date
    February 17, 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

    2-11-99 - FOLEY CATHETER WAS DUE TO BE DISCONTINUED. BALLOON COULD NOT BE DEFLATED VIA SYRINGE. QUESTION; BAD VALVE ON FOLEY. FOLEY BALLOON VALVE CUT, HOWEVER BALLOON REMAINED INFLATED. ATTEMPTED TO WITHDRAW WITH MODERATE TRACTION. HIGH RESISTANCE. PHYSICIAN NOTIFIED. 2-12-99 - UROLOGIST ATTEMPTED TO REMOVE FOLEY. SURGICAL STEEL INSERTED INTO BALLOON LUMEN AND UNABLE TO REMOVE ALL BALLOON CONTENTS. ALTHOUGH SOME CAME OUT. THE PT WAS SENT HOME WITH INSTRUCTIONS TO SEE MD ON MONDAY IF THE FOLEY DID NOT PASS ON ITS OWN OVER THE WEEKEND. 2-15-99 AS PER PHYSICIAN'S OFFICE NURSE: UNDER ULTRASOUND GUIDANCE, THE PHYSICIAN USED A BARD BIOPSY CUT WITH AN 18 GUAGE, 20 CENTIMETER NEEDLE. TWICE HE ATTEMPTED BY PUTTING PROBE IN RECTUM AND FIRED GUN. ON SECOND ATTEMPT, THE NEEDLE POPPED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C.R. BARD INC. #16 FR 5CC FOLEY CATH RIBBED BALLOON KOD C.R. BARD, INC. * 39J1B034

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other