BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL NEEDLE 22G X 8.9CM -3.5"

    MDR report key: 1212047 · Received October 24, 2008

    Report

    Report Number
    MW5008778
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 24, 2008
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    BSP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    BAXTER HEALTHCARE CORP HAD 20G 3.5 INCH SPINAL NEEDLES IN THE SPINAL NEEDLE PACKAGE MARKED 22G 3.5 IN NEEDLE. THE WRONG SIZE NEEDLES IN THE WRONG PACKAGE. THE NEEDLES COME IN BOXES OF 25 NEEDLES INDIVIDUALLY PACKAGED NEEDLES PER BOX. I SENT THREE BOXES BACK PLUS NOTIFIED CENTRAL SUPPLY AND ANESTHESIA OF THE PROBLEM. THE BOXES WERE RETURNED TO THE COMPANY. THE NEXT SHIPMENT RECEIVED A WEEK LATER HAD THE SAME MISMARKED NEEDLES. THE LOT NUMBER ON THE MISMARKED NEEDLES IS L8H09, THE LOT NUMBER ON THE CORRECTLY PACKAGED NEEDLES IS L8E278. WE USE SPINAL NEEDLES FOR EPIDURAL STEROID INJECTIONS, NERVE ROOT BLOCKS, FACET JOINT INJECTIONS, SI JOINT INJECTIONS AND LB PUNCTURES. THE 20 G SPINAL NEEDLES ARE TOO BIG FOR NERVE ROOT BLOCKS, SI JOINT/FACET JOINT INJECTIONS, THERE IS HIGHER RISK OF NERVE DAMAGE AND JOINT DAMAGE. EVENT REAPPEARED AFTER REINTRODUCTION?: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL NEEDLE 22G X 8.9CM -3.5" SPINAL NEEDLE 3.5" 22G BSP BAXTER HEALTHCARE CORP L8A309

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability