BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELLAN

    MDR report key: 20971455 · Received December 18, 2024

    Report

    Report Number
    1423537-2024-00350
    Event Type
    Malfunction
    Date Received
    December 18, 2024
    Report Date
    March 21, 2025
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    FMI
    PMA / PMN Number
    K012736
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) FOR LOT 24G003 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. PRIOR TO A LOT¿S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. DURING PRODUCTION, INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. THERE WERE NO SAMPLES RETURNED FOR EVALUATION, THEREFORE THE AFFECTED DEVICE(S) COULD NOT BE EVALUATED TO CONFIRM THE REPORTED FAILURE MODE. AS SUCH, A ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE 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
    2282750 MAGELLAN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI CARDINAL HEALTH, INC. 8881850510 24G003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown