BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGES (W/O NEEDLE)

    MDR report key: 13900959 · Received March 25, 2022

    Report

    Report Number
    13900959
    Event Type
    Malfunction
    Date Received
    March 25, 2022
    Date of Event
    March 1, 2022
    Report Date
    March 15, 2022
    Manufacturer
    DYNAREX CORPORATION
    Product Code
    FRN
    UDI-DI
    00616784699028
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE QUALITY OF THE WINGS AND PLUNGERS ON THE SYRINGE IS SUBPAR AND ARE BENDING UNDER PRESSURE WHILE ATTEMPTING INSERTION INTO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980239 SYRINGES (W/O NEEDLE) SYRINGE, PISTON FRN DYNAREX CORPORATION 6990 50359 00616784699028

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown