BEUDAMED
    FDA Adverse Event Other Summary report: N

    ECLIPSE BLOOD COLLECTION NEEDLE, 21GXL 1/4" MS

    MDR report key: 281375 · Received June 9, 2000

    Report

    Report Number
    9617032-2000-00001
    Event Type
    Other
    Date Received
    June 9, 2000
    Date of Event
    February 19, 2000
    Report Date
    June 9, 2000
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FMI
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 02/19/2000, A PHLEBOTOMIST WAS USING A STANDARD YELLOW NEEDLE HOLDER AND AN ECLIPSE 21 X 1 1/4 INCH BLOOD COLLECTION NEEDLE. PHLEBOTOMIST DID NOT HAVE THE APPROPRIATE SHARPS CONTAINER TO UNWIND THE NEEDLE FROM THE HOLDER; THEREFORE, PHLEBOTOMIST USED THE OTHER HAND TO UNWIND THE NEEDLE OFF THE HOLDER AFTER A BLOOD DRAW. THE SAFETY SHIELD DEVICE WAS PROPERLY ENGAGED. WHEN UNWINDING THE NEEDLE BY HAND, THE SAFETY SHIELD BROKE OFF AND IN TURN STUCK PHLEBOTOMIST. IT WAS RECOMMENDED BY CO'S STAFF THAT THE PRONTO QUIK RELEASE NEEDLE HOLDER BE USED TO DROP ALL NEEDLES INTO A SHARPS CONTAINER WITHOUT HANDLING THE NEEDLE WITH THE OPPOSITE HAND. THIS PROCEDURE IS RECOMMENDED BY THE ACCOUNT TO THEIR EMPLOYEES. SHELF CARTON GENERAL PRECAUTION STATES "AFTER SIMPLE USE, DISPOSE OF PRODUCT ACCORDING TO CO'S INSTITUTIONS REGULATIONS. DO NOT UNSCREW NEEDLE FROM HOLDER BY HAND." NO PRODUCT AVAILABLE FROM EVALUATION. LOT NUMBER UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE BLOOD COLLECTION NEEDLE, 21GXL 1/4" MS SND-ECLIPSE FMI BECTON DICKINSON AND COMPANY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other