BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELLAN

    MDR report key: 21396143 · Received February 18, 2025

    Report

    Report Number
    1423537-2025-00081
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    January 31, 2025
    Report Date
    April 24, 2025
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    FMI
    UDI-DI
    10884521000544
    PMA / PMN Number
    K012736
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS (DHR) FOR LOT 103305 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. NO SAMPLES WERE RETURNED FOR EVALUATION. INSTEAD, A VIDEO WAS PROVIDED AND THE REPORTED ISSUE OF LEAKING WAS OBSERVED. HOWEVER, THE INVESTIGATION DID NOT IDENTIFY A SYSTEMIC ISSUE WITH THE PRODUCT OR PROCESS, AND A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED BASED ON AVAILABLE INFORMATION. THEREFORE, A CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS NOT NECESSARY AT THIS TIME. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY INJECTED DEPOT TO RIGHT DELTOID AS REQUESTED BY PATIENT. WHILST DEPRESSING THE SYRINGE, MEDICATION BEGAN LEAKING FROM THE HYPODERMIC SAFETY NEEDLE DOWN THE PATIENTS ARM. IT APPEARED THE MEDICATION WAS LEAKING OUT FROM THE PLASTIC PART OF THE DEVICE BEFORE ENTERING THE STEEL LUMEN OF THE NEEDLE AS THE MEDICATION WAS BEING PUSHED THROUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1388084 MAGELLAN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI CARDINAL HEALTH, INC. 8881850310 103305 10884521000544

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown