BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELLAN HYPODERMIC SAFETY NEEDLE 25G X 1"

    MDR report key: 20212471 · Received September 12, 2024

    Report

    Report Number
    MW5159578
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    September 10, 2024
    Report Date
    September 11, 2024
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NURSE WAS ADMINISTERING EMPLOYEE FLU SHOTS. A NEEDLE WAS OPENED AND CORRECTLY SCREWED ON TO FLU SYRINGE, WHEN NEEDLE TIP WAS ENTERED IN TO ARM THE FLU VACCINE LEAKED AROUND THE PLASTIC TIP AT THE NEEDLE BASE. THE NEEDLE ITSELF DID NOT BREAK, ONLY THE PLASTIC LEAKED. THE NEEDLE IS MAGELLAN HYPODERMIC SAFETY NEEDLE 25G X 1", LOT NUMBER 24A103, EXPIRATION DATE 2028-10-31.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113385 MAGELLAN HYPODERMIC SAFETY NEEDLE 25G X 1" NEEDLE, HYPODERMIC, SINGLE LUMEN FMI CARDINAL HEALTH, INC. 24A103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown