BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY NEEDLE 25 G 1" FOR IMMUNIZATIONS

    MDR report key: 16313242 · Received February 6, 2023

    Report

    Report Number
    MW5114756
    Event Type
    Malfunction
    Date Received
    February 6, 2023
    Report Date
    February 2, 2023
    Manufacturer
    UNK
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FROM (B)(6) 2022, WE HAD 10 (TEN) NEEDLESTICK INCIDENTS WHERE MEDICAL PROFESSIONAL USED THE "SAFETY NEEDLE 25G 1" " TO PROVIDE IMMUNIZATIONS AND THE DEVICE WAS REPORTED TO BE FAULTY. EXAMPLES WERE "THE SAFETY CAP BENT OUT OF PLACE AFTER IMMUNIZATION AND PRICKED FINGERS", OR "THE SAFETY MECHANISM FAILED AND BROKE OFF AS THE PROVIDER WAS ENGAGING THE SAFETY CAP". LOT NUMBERS INVOLVED IN THIS INCLUDE THE FOLLOWING (2347801, 210207, 210307).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2313553 SAFETY NEEDLE 25 G 1" FOR IMMUNIZATIONS NEEDLE, HYPODERMIC, SINGLE LUMEN FMI UNK 2347801
    2313554 SAFETY NEEDLE 25 G 1" FOR IMMUNIZATIONS NEEDLE, HYPODERMIC, SINGLE LUMEN FMI UNK 210207
    2313555 SAFETY NEEDLE 25 G 1" FOR IMMUNIZATIONS NEEDLE, HYPODERMIC, SINGLE LUMEN FMI UNK 210307

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other