BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANISH POINT SYRINGE

    MDR report key: 1751387 · Received June 18, 2010

    Report

    Report Number
    1751387
    Event Type
    Malfunction
    Date Received
    June 18, 2010
    Date of Event
    June 15, 2010
    Report Date
    June 18, 2010
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    WHILE TRYING TO DRAW UP MEDICATION, INTO THE SUBCUTANEOUS SYRINGE, THE NEEDLE BROKE OFF. IT SEEMED LIKE THE SYRINGE WAS FLIMSEY. FIRST IT BENT AND THEN BROKE OFF. THE NEEDLE STAYED IN THE VIAL.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE SYRINGE NEEDLE BENT AND THEN BROKE OFF IN VIAL OF MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANISH POINT SYRINGE RETRACTABLE SYRINGE MEG RETRACTABLE TECHNOLOGIES, INC REF 10301 A090302

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR