BEUDAMED
    FDA Adverse Event Summary report: N

    VANISH POINT SYRINGE

    MDR report key: 3423406 · Received September 26, 2013

    Report

    Report Number
    3423406
    Date Received
    September 26, 2013
    Date of Event
    September 20, 2013
    Report Date
    September 26, 2013
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ADMINISTERED A FLU VACCINATION. THE VACCINATION ITSELF WAS GIVEN WITHOUT INCIDENT BUT ONCE THE NEEDLE RETRACTED, THE ENTIRE NEEDLE SYSTEM COMPLETELY FELL APART, INCLUDING THE SPRING FLEW ACROSS THE ROOM AND THE NEEDLE WAS TEMPORARILY LOST. THE NEEDLE WAS LATER FOUND IN THE HALLWAY. THE LOT NUMBER INVOLVED IN THIS INCIDENT WAS A120907. WE HAVE HAD 3 SIMILAR EVENTS IN THE PAST SEVERAL MONTHS. ALL HAVE INVOLVED THE LOT NUMBERS LISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487866 VANISH POINT SYRINGE RETRACTABLE NEEDLE/SYRINGE SYSTEM MEG RETRACTABLE TECHNOLOGIES, INC. 25G 1" 3CC A121009 & A120907

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other