BEUDAMED
    FDA Adverse Event Death Summary report: N

    BENSON STRAIGHT GUIDE WIRE

    MDR report key: 8129 · Received May 4, 1994

    Report

    Report Number
    8129
    Event Type
    Death
    Date Received
    May 4, 1994
    Date of Event
    April 15, 1994
    Report Date
    May 2, 1994
    Manufacturer
    UNIVERSAL MEDICAL INSTRUMENT CORP.
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PARASPLENIC ABCESS DRAINAGE. AS DESCRIBED IN PT RADIOLOGY REPORT, THE PT WAS PREPPED AND DRAPED IN THE USUAL STERILE MANNER. A NEEDLE AND GUIDE WIRE WERE CAREFULLY POSITIONED INTO THE ABCESS. AT THIS POINT, THE PT SUDDENLY STARTED FIGHTING AGAINST THE NEEDLE AND BROKE OFF THE TIP OF THE WIRE. THE PT WAS MONITORED FOR ONE HR-STABLE. SIX HRS LATER, THE PT WAS FOUND TO BE SHORT OF BREATH AND TACHYCARDIC. PT RETURNED FOR CT OF CHEST. A CHEST TUBE WAS PLACED FOR A LARGE PLEURAL EFFUSION. PT EXPIRED ON 4/26/94.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BENSON STRAIGHT GUIDE WIRE GUIDE WIRE DQX UNIVERSAL MEDICAL INSTRUMENT CORP. 137982

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death