BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1269744 · Received December 18, 2008

    Report

    Report Number
    1269744
    Event Type
    Malfunction
    Date Received
    December 18, 2008
    Date of Event
    December 10, 2008
    Report Date
    December 18, 2008
    Manufacturer
    C.R. BARD, INC. BARD MEDICAL DIVISION
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TWO NURSES ATTEMPTED TO DISCONTINUE JACKSON PRATT DRAIN FROM PATIENT'S VAGINAL AREA AND FELT RESISTANCE THEN STOPPED. CHARGE NURSE WAS INFORMED THERE WERE NO SUTURES HOLDING JP DRAIN IN PLACE. ASSESSED VAGINAL AREA, ADD'L ATTEMPT MADE WITHOUT EXCESSIVE FORCE TO REMOVE BUT TUBING SNAPPED WITHOUT THE TIP. SMALL AMOUNT OF TUBING WAS FELT, EXAMINED VAGINAL AREA WITH LIGHT AND NOTICED TIP INSIDE, ATTEMPTED UNSUCCESSFULLY TO REMOVE. PATIENT'S DOCTOR NOTIFIED AND DOCTOR'S PHY ASST CAME, COMPLETED VAGINAL EXAM, BUT WAS UNABLE TO PALPATE ANY REMAINS OF JP IN VAGINA. A PELVIC X-RAY WAS ORDERED AND REVEALED A 2.5CM PIECE OF DRAIN IN PELVIC AREA. ANOTHER PHY ASST EXAMINED THE PATIENT, SPOKE TO PHYSICIAN, AND DETERMINED PATIENT WOULD REQUIRE GOING TO OR TO HAVE IT REMOVED. ON 12/12/08 THE PATIENT WAS TAKEN TO OR AND PIECE OF TUBING WAS SUCCESSFULLY REMOVED. CLEAR PLASTIC TUBING MEASURING 2.5CM X0.2 CM SENT TO PATHOLOGY. OTHER TUBING REMOVED FROM VAGINAL AREA WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CATHETER, DRAINAGE GCY C.R. BARD, INC. BARD MEDICAL DIVISION * NGSF3297

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR NO OTHER THERAPIES| NO OTHER THERAPIES