BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOJECT SAFETY NDL 25 X 1

    MDR report key: 17851562 · Received October 2, 2023

    Report

    Report Number
    1282497-2023-10798
    Event Type
    Malfunction
    Date Received
    October 2, 2023
    Date of Event
    September 13, 2023
    Report Date
    March 13, 2024
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    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

    THIS REPORT WAS FILED IN ERROR. CARDINAL HEALTH IS NOT THE LEGAL MANUFACTURER OF THIS THIS DEVICE. THE LEGAL MANUFACTURER IS SOL MILLENNIUM MED INC. THE MANUFACTURER HAS BEEN NOTIFIED OF THE EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE NEEDLE LEAKED VACCINE BEFORE BEING ADMINISTERED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023 STATED THAT THE LEAK HAPPENED AT THE LUER LOCK. VACCINE WAS A PREFILLED VIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1836303 MONOJECT SAFETY NDL 25 X 1 NEEDLE, HYPODERMIC, SINGLE LUMEN FMI CARDINAL HEALTH 1182510 02105121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown