BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITHS MEDICAL HYPODERMIC NEEDLE PRO EDGE SAFETY DEVICE 25GX1IN

    MDR report key: 22884008 · Received August 25, 2025

    Report

    Report Number
    MW5175181
    Event Type
    Malfunction
    Date Received
    August 25, 2025
    Date of Event
    August 18, 2025
    Report Date
    August 19, 2025
    Manufacturer
    SMITHS MEDICAL/ICU MEDICAL INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PREVNAR 20 MEDICATION WAS LEAKING PRIOR TO ADMINISTRATION. PATIENT DID NOT RECEIVE FULL DOSE OF MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2723244 SMITHS MEDICAL HYPODERMIC NEEDLE PRO EDGE SAFETY DEVICE 25GX1IN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI SMITHS MEDICAL/ICU MEDICAL INC. 4354484

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other