BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE, HYPODERMIC, SINGLE LUMEN

    MDR report key: 12413956 · Received September 2, 2021

    Report

    Report Number
    12413956
    Event Type
    Malfunction
    Date Received
    September 2, 2021
    Date of Event
    July 11, 2021
    Report Date
    July 23, 2021
    Manufacturer
    ENDURE INDUSTRIES, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RN STATES : "WHEN THE RN ATTEMPTED TO ENGAGE THE NEEDLE GUARD AGAINST A HARD SURFACE TO LOCK IT, THE NEEDLE HUB POPPED OFF OF THE SYRINGE. CONFIRMED WITH THE SAME TYPE OF NEEDLE AND MULTIPLE TYPES OF SYRINGES, THE NEEDLE WILL NOT COMPLETELY LOCK TO THE SYRINGE DESPITE TURNING AS HARD AS POSSIBLE. WITH MINIMAL PRESSURE, THE NEEDLE HUB WILL POP OFF OF THE LUER LOCK. MANAGEMENT, SUPPLY & DISTRIBUTION (S&D), AND HOUSE MANAGER NOTIFIED." PRODUCT FAILURE FORM COMPLETED AND SENT TO S&D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1311815 NEEDLE, HYPODERMIC, SINGLE LUMEN FMI ENDURE INDUSTRIES, INC. 191116

    Patients

    Seq Age Sex Outcome Treatment
    1 15330 DA