BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELLAN

    MDR report key: 19515010 · Received June 11, 2024

    Report

    Report Number
    1423537-2024-00026
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Report Date
    September 18, 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

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

    Additional Manufacturer Narrative · 0

    SECTIONS D1 AND D4 WERE UPDATED WITH THE DEVICE INFORMATION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 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. PHOTOS WERE PROVIDED AND THE REPORTED ISSUE WAS OBSERVED HOWEVER NO PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION THEREFORE THE AFFECTED DEVICE(S) COULD NOT BE EVALUATED. 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

    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. ONE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED ISSUE WAS OBSERVED. THE¿INVESTIGATION DID NOT IDENTIFY A SYSTEMIC ISSUE WITH THE PRODUCT OR PROCESS. 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 A 23G NEEDLE WAS OBSERVED TO HAVE A CRACK IN THE PLASTIC PART OF THE NEEDLE. RESIDUES OF A DRY, WHITE SOLUTION WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219101 MAGELLAN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI CARDINAL HEALTH, INC. 8881850310 112744 10884521000544

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown