BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAFETY NEEDLE

    MDR report key: 16919582 · Received May 11, 2023

    Report

    Report Number
    MW5117487
    Event Type
    Other
    Date Received
    May 11, 2023
    Report Date
    May 11, 2023
    Manufacturer
    DUOPROSS MEDITECH CORPORATION
    Product Code
    FMI
    UDI-DI
    06971352289020
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE NEEDLE IS VERY FLIMSY. IT BENDS WHEN TRYING TO PENETRATE A MEDICATION VIAL, I HAVE ALSO SEEN IT BEND WHEN TRYING TO GIVE AN INJECTION (ON A HUMAN). AND NOW TODAY, THE NEEDLE WAS SO FLIMSY IT BENT WHEN TRYING TO ACTIVATE THE SAFETY CAP OVER THE NEEDLE. SO ONLY A SMALL PORTION OF THE NEEDLE IS IN THE SAFETY CAP AND A LARGER PORTION OF THE SHARP NEEDLE IS PROTRUDING OUTSIDE OF THE EDGES OF THE SAFETY CAP. (B)(6). SUBMISSION ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1352295 SAFETY NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI DUOPROSS MEDITECH CORPORATION 100800000066 W2106077 06971352289020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown