BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELLAN HYPODERMIC SAFETY NEEDLE 25G 1"

    MDR report key: 20901888 · Received December 11, 2024

    Report

    Report Number
    20901888
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Date of Event
    October 24, 2024
    Report Date
    November 12, 2024
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS ADMINISTERED AN INFLUENZA VACCINE IN LEFT DELTOID USING PROPER IM ADMINISTRATION TECHNIQUE. UPON ADMINISTRATION THE VACCINE SOLUTION RAN OUT OF THE SYRINGE AND DOWN PATIENT'S ARM INSTEAD OF INJECTING THROUGH THE NEEDLE. THERE WAS MORE TENSION FELT WITH ATTEMPT TO INJECT THAN USUAL. THE NEEDLE APPEARED TO NOT ALLOW ANY VACCINE SOLUTION THROUGH. THE PATIENT DID NOT RECEIVE ANY OF THE VACCINE. THE ENTIRE AMOUNT OF VACCINE SOLUTION LEAKED OUT THROUGH BASE OF VIAL THAT CONNECTS TO THE NEEDLE. DISCUSSED WITH MD AND GNP AND PATIENT AND PATIENT WANTED VACCINE READMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2596670 MAGELLAN HYPODERMIC SAFETY NEEDLE 25G 1" NEEDLE, HYPODERMIC, SINGLE LUMEN FMI CARDINAL HEALTH 8881850510 24G003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown