BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELLAN

    MDR report key: 8175460 · Received December 17, 2018

    Report

    Report Number
    MW5082214
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    December 12, 2018
    Report Date
    December 13, 2018
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    MEDICAL ASSISTANT WAS GETTING READY TO GIVE A VACCINE TO PATIENT. WHEN SHE REMOVED THE HUB FROM THE NEEDLE SHE NOTICED FIBERS ON THE NEEDLE. LOT# 821923, LAWSON# (B)(4), EXP. DATE 7/31/2023. WE REMOVED THE ADDITIONAL 6 NEEDLES LEFT IN THE MED ROOM AND DISPOSED OF THEM INTO THE SHARPS CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012000 MAGELLAN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI COVIDIEN 821923
    1012001 MAGELLAN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI COVIDIEN 821923
    1012002 MAGELLAN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI COVIDIEN 821923
    1012003 MAGELLAN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI COVIDIEN 821923
    1012004 MAGELLAN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI COVIDIEN 821923
    1012005 MAGELLAN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI COVIDIEN 821923
    1012006 MAGELLAN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI COVIDIEN 821923

    Patients

    Seq Age Sex Outcome Treatment
    1