BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 25GX1 PRO EDGE SAFETY DEVICE 100/BX

    MDR report key: 11260361 · Received January 29, 2021

    Report

    Report Number
    MW5099104
    Event Type
    Malfunction
    Date Received
    January 29, 2021
    Date of Event
    January 27, 2021
    Report Date
    January 27, 2021
    Manufacturer
    SMITHS MEDICAL/ SMITHS MEDICAL ASD, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN DRAWING UP A MEDICATION THE NEEDLE 25GX1" NEEDLE-PRO EDGE SAFETY DEVICE 100/BX, 10 BX/CA 3010043/SMITHS MEDICAL ASD, INC-402510 BENDS VERY EASILY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146024 NEEDLE 25GX1 PRO EDGE SAFETY DEVICE 100/BX NEEDLE, HYPODERMIC, SINGLE LUMEN FMI SMITHS MEDICAL/ SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1