BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDEX FOLEY CATHETER

    MDR report key: 104758 · Received July 9, 1997

    Report

    Report Number
    104758
    Event Type
    Injury
    Date Received
    July 9, 1997
    Date of Event
    May 30, 1997
    Report Date
    June 10, 1997
    Manufacturer
    C.R. BARD, INC. BARD UROLOGICAL DIVISION
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT FOUND IN BATHROOM. FOLEY FOUND AT BEDSIDE WITH TUBING SHEARED AND BALLOON MISSING. BALLOON RETAINED IN PT REMOVED VIA CYSTO WITHOUT COMPLICATION. THE CATHETER WAS PLACED URETHRALLY. THE PT WAS AN 83 Y/O MALE, WEIGHING 215 POUNDS, ADMITTED WITH A DIAGNOSIS OF CHF. THE CATHETER WAS PLACED FOR URINARY INCONTINENCE THAT HAD BEEN INCREASING OVER THE PAST 8 MONTHS. THE PT HAS A LONG MEDICAL AND SURGICAL HISTORY. THE PT IS MENTALLY COMPETENT BUT IS MILDLY CONFUSED ON OCCASION. THE PT HAS HAD SOME GAIT DETERIORIZATION, AND WALKS WITH STAGGERED AND SHUFFLING FEET. THE PT INADVERTENTLY TRAVELLED FROM HIS BED TO THE BATHROOM WITH A FOLEY CONNECTED (APPROX. 12 FT.). THE FOLEY BROKE WHILE STILL INDWELLING. A KUB X-RAY WAS DONE WHICH CONFIRMED THE PRESENCE OF A FOREIGN BODY IN THE BLADDER. NO ADD'L TESTS WERE DONE POST CYSTOSCOPY AND THE PT WAS DISCHARGED WITHOUT FURTHER PROBLEMS. THE CATHETER WAS REPLACED WITHOUT COMPLICATION. THE SMALL PORTION OF THE CATHETER THAT WAS RETRIEVED FROM THE BLADDER THROUGH CYSTOSCOPY HAS BEEN RETAINED IN THE RM DEPT. THERE WERE NO IDENTIFICATION NUMBERS ON THE PORTION OF CATHETER THAT WAS RETRIEVED. THERE APPEARS TO BE NO PERMANENT INJURY TO THE PT, FACILITY IS WILLING TO PROVIDE THE AVAILABLE PORTION OF THE CATHETER TO BARD, FOR THEIR QA EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARDEX FOLEY CATHETER FOLEY CATHETER LJT C.R. BARD, INC. BARD UROLOGICAL DIVISION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention