BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW INTERNATIONAL, INC.

    MDR report key: 21214 · Received July 21, 1994

    Report

    Report Number
    21214
    Event Type
    Injury
    Date Received
    July 21, 1994
    Date of Event
    February 1, 1994
    Report Date
    February 9, 1994
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    KZH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOLLOWING EPIDURAL INJECTION (LEB) BY THE ATTENDING PHYSICIAN, THE PLASTIC SYRINGE BULB SEPARATED FROM THE NEEDLE SHANK, THUS LEAVING THE EPIDURAL NEEDLE IN THE PATIENT'S BACK. THE PHYSICIAN HAD TO REMOVE THE NEEDLE USING GAUZE SPONGES TO GRIP AND WITHDRAW IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW INTERNATIONAL, INC. LUMBAR EPIDURAL STEROID SYRINGE KZH ARROW INTERNATIONAL, INC. B-291-3

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention