BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECTON DICKINSON

    MDR report key: 279865 · Received May 24, 2000

    Report

    Report Number
    2618282-2000-00004
    Event Type
    Malfunction
    Date Received
    May 24, 2000
    Date of Event
    April 3, 2000
    Report Date
    May 18, 2000
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    FEZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD A VAGINAL HYSTERECTOMY WITH ANTERIOR/POSTERIOR REPAIR AND PLACEMENT OF THE BONANNO SUPRAPUBLIC BLADDER DRAINAGE CATHETER. PT WENT HOME ON 3/27/2000. ON SUNDAY 4/2/00, PT CALLED PHYSICIAN BECAUSE CATHETER WAS LEAKING AT THE INSERTION SITE. PHYSICIAN THOUGHT PERHAPS BLADDER WAS MORE FULL THAN PT THOUGHT. TOLD PT TO UNCLAMP AND DRAIN MORE OFTEN. EVEN AFTER EMPTYING THE BAG THE PT'S BLADDER FELT FULL. ON MONDAY 4/3/00, PT CALLED PHYSICIAN AND TOLD PHYSICIAN THE CATHETER WASN'T WORKING. PHYSICIAN TOLD THE PT TO COME TO THE OFFICE WHERE PHYSICIAN ATTEMPTED TO REMOVE THE CATHETER. AS PHYSICIAN ATTEMPTED THE REMOVAL, PHYSICIAN FOUND IT WAS BROKEN NECESSITATING THE PT TO GO TO A UROLOGIST FOR A CYSTOSCOPY TO REMOVE THE PIGTAIL PORTION OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECTON DICKINSON BONANNO SUPRAPUBIC BLADDER DRAINAGE CATHETER FEZ BECTON DICKINSON CARIBE LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention