BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE, EPIDURAL

    MDR report key: 312704 · Received January 15, 2001

    Report

    Report Number
    MW1020822
    Event Type
    Malfunction
    Date Received
    January 15, 2001
    Date of Event
    January 3, 2001
    Report Date
    January 12, 2001
    Manufacturer
    BECTON DICKINSON
    Product Code
    FME
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PLACING AN EPIDURAL CATHETER PRE-OP FOR A CONTINUOUS EPIDURAL, PART OF THE B-D EPIDURAL GLASS SYRINGE (THE TOP OF THE PLUNGER) SHATTERED UNDER THE "MDA'S" THUMB. THE "MDA" WAS INJECTING A 5CC TEST DOSE THROUGH THE EPIDURAL CATHETER. THE SYRINGE HAD ONLY BEEN USED FOR COMPRESSING AIR WITH THE LOSS OF RESISTANCE TECHNIQUE FOR PLACING THE EPIDURAL NEEDLE PREVIOUSLY. ONLY THE PART OF THE SYRINGE DESIGNED FOR THUMB PRESSURE SHATTERED (INTO MANY PIECES). THERE WAS NO EXCESSIVE OR UNUSUAL PRESSURE USED. THE SYRINGE WAS A COMPONENT IN THE BAXTER SPINAL ANESTHESIA TRAY #2T0661, LOT NO. GD722603, EXP 8/8/2001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1658 SYRINGE, EPIDURAL EPIDURAL SYRINGE FME BECTON DICKINSON A COMPONENT IN BAXTER TRAY-GD722603

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other EXPIRATION DATE 8/8/01.| BAXTER SPINAL ANES TRAY 2T0661.LOT#: GD722603.