BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 25G 1IN

    MDR report key: 20795156 · Received November 26, 2024

    Report

    Report Number
    MW5162902
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    November 4, 2024
    Report Date
    November 22, 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

    #10069327---PRODUCT QUALITY ISSUE, 10069892---SYRINGE LEAK FROM JPSR(JOINT PATIENT SAFETY REPORTING SYSTEM): NURSE WAS GIVING FLU VACCINE HIGH DOSE AND VACCINE LEAKED OUT OF SYRINGE, LOT # UT8437DA, EXP 2025/06, INFLUENZA VACCINE FLUZONE HIGH DOSE 0.5ML SINGLE DOSE, SANOFI PASTEUR INC.; LOT# 4326210, EXP 2027/08/30; HYPO NEEDLE PRO 25GX1IN SMITHS MEDICAL ASD INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831454 NEEDLE 25G 1IN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female INFLUENZA VIRUS VACCINE INJ