BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANISHPOINT SYRINGE

    MDR report key: 3122013 · Received May 14, 2013

    Report

    Report Number
    MW5030229
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AFTER INJECTING VACCINE INTO INFANT, THE BUTTON, NEEDLE, AND SPRING SHOT OUT OF THE BACK OF THE BARREL. THE SPRING GRAZED THE CHEEK OF THE EMPLOYEE RESULTING IN NO INJURY. THE BUTTON, NEEDLE, SPRING, AND SYRINGE WERE RECOVERED. THE PLUNGER WAS NOT RECOVERED. THIS SAME INCIDENT OCCURRED WITH A SYRINGE FROM THE SAME LOT BUT A DIFFERENT SIZE ON (B)(6) 2013, REPORTED ON (B)(6) 2013 TO MEDWATCH. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213178 VANISHPOINT SYRINGE VANISHPOINT SYRINGE MEG RETRACTABLE TECHNOLOGIES, INC. 25G X 1" A120902

    Patients

    Seq Age Sex Outcome Treatment
    1