BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELLAN

    MDR report key: 20469983 · Received October 17, 2024

    Report

    Report Number
    1423537-2024-00249
    Event Type
    Malfunction
    Date Received
    October 17, 2024
    Report Date
    January 2, 2025
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    FMI
    UDI-DI
    10884521000544
    PMA / PMN Number
    K012736
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) FOR LOT 112744 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 PRE-FILLED SYRINGE LEAKING AT THE THREAD. THE USER TRIED TO STOP THE INJECTION FROM LEAKING FURTHER BY TIGHTENING THE NEEDLE MORE FIRMLY THEN THE CONNECTING PART BETWEEN THE NEEDLE AND SYRINGE HAD SUBSEQUENTLY BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248964 MAGELLAN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI CARDINAL HEALTH, INC. 8881850310 112744 10884521000544

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown