BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH, INC.

    MDR report key: 23896061 · Received December 26, 2025

    Report

    Report Number
    1423537-2025-00519
    Event Type
    Malfunction
    Date Received
    December 26, 2025
    Date of Event
    December 10, 2025
    Report Date
    March 16, 2026
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    FMI
    UDI-DI
    10884521000568
    PMA / PMN Number
    K012736
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. 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. THE LOT MET ALL DEFINED ACCEPTANCE REQUIREMENTS AND WAS RELEASED. ONE DEVICE WAS RECEIVED FOR INVESTIGATION. THE DEVICE WAS EVALUATED; THE SAFETY SHIELD WAS ACTIVATED AND CLOSED PROPERLY, SECURING THE NEEDLE. THE SAMPLE DID NOT CONFIRM THE REPORTED CONDITION. THE INVESTIGATION DID NOT IDENTIFY A SYSTEMIC ISSUE WITH THE PRODUCT OR PROCESS. THEREFORE, A CORRECTIVE AND PREVENTIVE ACTION IS NOT NECESSARY AT THIS TIME. 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 THEY HAVE BEEN EXPERIENCING SAFETY CONCERNS AND ALSO A NEEDLE STICK WITH THE CARDINAL MAGELLAN HYPODERMIC SAFETY NEEDLE 25G X 1¿, 8881850510, LOT 25G254. THIS NEEDLE IS BEING USED AS A SUB FOR THE BACKORDERED BD NEEDLE 305916. THE PRACTICE HAS NOTED THE PRODUCT HAS A DEFECTIVE SAFETY LOCK ON THE NEEDLES AND HAVE EXPERIENCED ON MULTIPLE DIFFERENT USES THAT WHEN CLOSING THE SAFETY MECHANISM, THE NEEDLE HAS REMAINED OUT. THE NEEDLE WILL ALSO BEND FORWARD AND MISS THE SAFETY LOCK ALL TOGETHER, OVERALL, THEY ARE FLIMSY AND POOR QUALITY. THESE NEEDLES ARE BEING USED FOR IM INJECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3427 CARDINAL HEALTH, INC. NEEDLE, HYPODERMIC, SINGLE LUMEN FMI CARDINAL HEALTH, INC. 8881850510 25G254 10884521000568

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown