BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 25G 1IN

    MDR report key: 20854939 · Received December 4, 2024

    Report

    Report Number
    MW5163216
    Event Type
    Malfunction
    Date Received
    December 4, 2024
    Date of Event
    November 13, 2024
    Report Date
    December 3, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NEEDLE ISSUE; (B)(6)---PRODUCT QUALITY ISSUE FROM JPSR: EMPLOYEE CAME FOR FLU VACCINE. THIS WRITER LOOKED AT NEEDLE PRIOR TO SCREWING IT ON THE SYRINGE, IT APPEARED TO HAVE SMOOTH THREADS THAT ARE ALL THERE THAT WOULD ALLOW IT TO SCREW ON WITHOUT GAPS. NEEDLE WAS NOT OVERTIGHTENED. NEEDLE WAS PRIMED PRIOR TO ADMINISTERED. FLU VACCINE ADMINISTERED. FLUID LEAKED OUT OF NEEDLE. NEEDLE LOT NUMBER: 4333134, 2027-09-27, SMITHS MEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2290674 NEEDLE 25G 1IN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI SMITHS MEDICAL ASD, INC. 4333134

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female