BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPOTHERMIC NEEDLE-PRO 25G

    MDR report key: 15716206 · Received November 1, 2022

    Report

    Report Number
    MW5113040
    Event Type
    Malfunction
    Date Received
    November 1, 2022
    Date of Event
    October 31, 2022
    Manufacturer
    SMITHS MEDICAL ASD INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2022, LVN WAS PULLING VACCINE OFF A VIAL WHEN HE NOTICED THAT THE NEEDLE WAS BENT AROUND 3/4 CLOSER TO THE BEVEL. UPON ASSESSMENT BY SUPERVISOR, SUPERVISOR FOUND OUT THAT THE NEEDLE BENT AS SOON AS THE VACCINATOR ATTEMPT TO INSERT THE NEEDLE INTO THE VIAL. MANUFACTURER: SMITHS MEDICAL ASD INC. HYPOTHERMIC NEEDLE-PRO 25GX 1 IN. REF # 402510. LOT # 4227006. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2950038 HYPOTHERMIC NEEDLE-PRO 25G NEEDLE, HYPODERMIC, SINGLE LUMEN FMI SMITHS MEDICAL ASD INC. 4227006

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown