BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPODERMIC NEEDLE-PRO EDGE SAFET

    MDR report key: 23497900 · Received November 7, 2025

    Report

    Report Number
    MW5178634
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    October 31, 2025
    Report Date
    November 4, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC. / ICU MEDICAL, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NEEDLE ISSUE - SMITHS MEDICAL HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE 25G X 1 IN REF (B)(4), LOT 6100817, EXP 03/05/2030. STAFF HAD ATTACHED FLU VACCINE TO THE NEEDLE TO GIVE TO PATIENT. UPON PROCEEDING TO INJECT THE VACCINE, THE SYRINGE POPPED OUT/DISCONNECTED FROM THE NEEDLE WHILE IT WAS IN THE PATIENT'S ARM. THIS HAPPENED DESPITE STAFF CHECKING SEVERAL TIMES THAT THE NEEDLE WAS APPROPRIATELY TWISTED AND LOCKED IN PLACE WITH THE SYRINGE. WE HAVE HAD PRIOR ISSUES WITH THE CONNECTION OF THIS NEEDLE TO SYRINGE WHERE THERE'S LEAKING OF VACCINE/MEDICATION FROM THE CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186163 HYPODERMIC NEEDLE-PRO EDGE SAFET NEEDLE, HYPODERMIC, SINGLE LUMEN FMI SMITHS MEDICAL ASD, INC. / ICU MEDICAL, INC. 6100817

    Patients

    Seq Age Sex Outcome Treatment
    1 Female