BEUDAMED
    FDA Adverse Event Other Summary report: N

    JMS SINGAPORE PTE LTD

    MDR report key: 410105 · Received August 8, 2002

    Report

    Report Number
    MW1025804
    Event Type
    Other
    Date Received
    August 8, 2002
    Date of Event
    July 30, 2002
    Report Date
    August 8, 2002
    Manufacturer
    JMS SINGAPORE PTE LTD
    Product Code
    FIE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DIALYSIS SVC WAS PROVIDING A FIVE-HR DIALYSIS TREATMENT TO A HOSPITALIZED PT. THE PT'S RIGHT FOREARM GRAFT WAS ACCESSED WITH JMS 15 GAUGE NEEDLES. ACCESSING THE GRAFT WAS UNEVENTFUL, REQUIRING ONE STICK FOR THE ARTERIAL INSERTION AND ONE FOR THE VENOUS SIDE INSERTION. DIALYSIS WAS STARTED AND THE PUMP SPEED INCREASED TO 400CC PER MIN. AT ONE HR AND FIVE MINS INTO THE TREATMENT IT WAS NOTED THAT BLOOD WAS LEAKING FROM A HOLE IN THE VENOUS NEEDLE. THERE APPEARED TO BE A DEFECT AT THE JUNCTION OF THE FLEXIBLE TUBING/PIGTAIL AND THE HARD PLASTIC LUERLOCK. DIALYSIS WAS STOPPED. THE ESTIMATED BLOOD LOSS WAS 300CC. A STAT HEMATOCRIT WAS DRAWN. THE PT'S PHYSICIAN WAS NOTIFIED. NO TRANSFUSION WAS GIVEN, AND THE PT'S VITAL SIGNS WERE STABLE. UPON CLOSER EVALUATION OF THE NEEDLE AND ITS TUBING THERE WAS CLEARLY A DEFECT/HOLE IN THE TUBING WITH A WHITE OPACITY ENCIRCLING THE TUBING NEAR THE HOLE. THIS OPACITY WAS ABOUT 1 MM WIDE. AFTER FORTY MINS A NEW VENOUS NEEDLE WAS INSERTED AND THE DIALYSIS TREATMENT WAS COMPLETED WITHOUT ANY FURTHER EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JMS SINGAPORE PTE LTD DIALYSIS A/V FISTULA NEEDLE FIE JMS SINGAPORE PTE LTD 820-2513 TWIN 010313681

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other 2) FRESENIUS F-8 DIALYZER.| 1) GAMBRO C-3 DIALYSIS MACHINE.