BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELLAN HYPODERMIC SAFETY NEEDLE 25 G X 5/8 INCHES

    MDR report key: 12513270 · Received September 21, 2021

    Report

    Report Number
    MW5104141
    Event Type
    Malfunction
    Date Received
    September 21, 2021
    Date of Event
    September 16, 2021
    Report Date
    September 20, 2021
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS RECEIVING SUB CUTANEOUS INJECTION OF CHEMOTHERAPY (VIDAZA). THE SECOND SYRINGE STARTED TO GET A DROP OF CHEMO COMING OUT OF THE NEEDLE. NURSE VERIFIED THE CONNECTION WAS TIGHT AND CONTINUED INJECTION WITH A GAUZE ON THE PATIENT AND NOTICED THE DROP CAME OUT FROM THE NEEDLE, NOT THE CONNECTION. PHARMACY WAS NOTIFIED. THERE ARE 2 LOT NUMBERS BECAUSE I DON'T KNOW WHICH NEEDLE WAS ON WHICH SYRINGE. THERE WERE 2 AFFECTED LOTS 111923 AND 110967 OF 25G 5/8", BOTH EXPIRING 2/28/2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400644 MAGELLAN HYPODERMIC SAFETY NEEDLE 25 G X 5/8 INCHES NEEDLE, HYPODERMIC, SINGLE LUMEN FMI CARDINAL HEALTH, INC. 111923
    1400645 MAGELLAN HYPODERMIC SAFETY NEEDLE 25 G X 5/8 INCHES NEEDLE, HYPODERMIC, SINGLE LUMEN FMI CARDINAL HEALTH, INC. 110967

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other