BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DROPSAFE 25G NEEDLE

    MDR report key: 15347899 · Received September 1, 2022

    Report

    Report Number
    MW5111832
    Event Type
    Malfunction
    Date Received
    September 1, 2022
    Date of Event
    August 29, 2022
    Report Date
    August 30, 2022
    Manufacturer
    HTL-STREFA, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DROPSAFE 25G NEEDLE (LOT #:SN25250064) BENT WHILE DRAWING UP VACCINE FROM VIAL AND BENT WHILE ADMINISTERING VACCINE IN A PATIENT. SMITH MEDICAL 25G NEEDLE (LOT #: 4191962) BENT WHILE RN WAS CAPPING THE NEEDLE AFTER DRAWING UP VACCINE. BOTH ARRIVED IN THE COVID-19 ANCILLARY KITS WHEN WE ORDER VACCINES. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300336 DROPSAFE 25G NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI HTL-STREFA, INC. SN25250064
    300337 SMITH MEDICAL 25G NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI SMITHS MEDICAL ASD, INC. 4191962

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown