BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDEX FOLEY CATHETER

    MDR report key: 107575 · Received July 3, 1997

    Report

    Report Number
    107575
    Event Type
    Injury
    Date Received
    July 3, 1997
    Date of Event
    January 20, 1997
    Report Date
    January 22, 1997
    Manufacturer
    BARD UROLOGICAL DIVISION C.R. BARD INC.
    Product Code
    KOD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SEVEN YEAR OLD MALE WAS PRE-CATHETERIZED FOR A VOIDING CYSTOGRAM. A 10 FR CATHETER WAS INSERTED UNDER STERILE CONDITIONS UNTIL RESISTANCE WAS MET. BALLOON WAS INFLATED WITH APPROX. 3 CC WATER. AFTER THE CATHETER WAS PLACED, DYE WAS THEN ADMINISTERED BUT THE DYE WOULD NOT FLOW THROUGH TUBING. THE RADIOLOGIST WAS CALLED AND HE DETERMINED IMPROPER PLACEMENT. THE NURSE DEFLATED THE BALLOON. WHEN THE CATHETER WAS REMOVED, BLOOD CAME OUT. THE PT THEN REQUIRED SURGERY FOR A TEAR IN THE URETHRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARDEX FOLEY CATHETER 10 FR 3 CC RIBBED BALLOON PEDIATRIC LUBRICA KOD BARD UROLOGICAL DIVISION C.R. BARD INC. * 39KDB015

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization| R