BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOJECT SAFETY NDL 25 X 1

    MDR report key: 18241671 · Received November 30, 2023

    Report

    Report Number
    1282497-2023-10809
    Event Type
    Malfunction
    Date Received
    November 30, 2023
    Report Date
    January 25, 2024
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FMI
    UDI-DI
    10884521544680
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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.

    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 A FAULTY SAFETY DEVICE AND STATED THAT WHEN YOU WENT TO CLOSE THE SAFETY CLIP IT EITHER BENT THE NEEDLE OR THE CLIP DID NOT CLICK INTO PLACE LEAVING THE NEEDLE EXPOSED RESULTING IN A NEEDLE STICK. BLOOD WORK WAS DONE ON THE PATIENT AND EMPLOYEE INVOLVED PER THEIR PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429464 MONOJECT SAFETY NDL 25 X 1 NEEDLE, HYPODERMIC, SINGLE LUMEN FMI CARDINAL HEALTH 1182510 02112003 10884521544680

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown