BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITHS MEDICAL HYPODERMIC NEEDLE PRO EDGE SAFETY DEVICE 25G 1 INCH

    MDR report key: 20397920 · Received October 7, 2024

    Report

    Report Number
    MW5160772
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    September 23, 2024
    Report Date
    October 2, 2024
    Manufacturer
    SMITH MEDICAL ASD, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS FOUND UPON USE OF NEEDLE WHILE GIVING VACCINATIONS THAT MEDICATION WAS LEAKING OUT FROM THE LUER HUB OF THE NEEDLE. THIS HAS HAPPED ON SEVERAL OCCASIONS. (B)(6) HAS PULLED THIS LOT NUMBER AND REPLACED WITH ANOTHER NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1934735 SMITHS MEDICAL HYPODERMIC NEEDLE PRO EDGE SAFETY DEVICE 25G 1 INCH NEEDLE, HYPODERMIC, SINGLE LUMEN FMI SMITH MEDICAL ASD, INC. 4326794

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown