BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANISH POINT SYRINGE, 3CC 23GX1"

    MDR report key: 1657865 · Received April 7, 2010

    Report

    Report Number
    MW5015502
    Event Type
    Malfunction
    Date Received
    April 7, 2010
    Date of Event
    April 6, 2010
    Report Date
    April 7, 2010
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CLEAR SUBSTANCE NOTED IN BARREL OF SYRINGES. APPEARS TO BE LUBRICANT THAT IS VISIBLE AND MOVES WITHIN THE BARREL OF SYRINGE WHEN PLUNGER IS MOVED. REPORTED TO THE COMPANY WHO OPENED A COMPLAINT. THEY WILL SEND MAILER BY 04/09/10 SO THAT WE MAY RETURN SYRINGES TO THEM FOR QA ANALYSIS. NO KNOWN INJURY HAS RESULTED FROM THE USE OF THESE SYRINGES. DIAGNOSIS: IMMUNIZATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANISH POINT SYRINGE, 3CC 23GX1" SYRINGE MEG RETRACTABLE TECHNOLOGIES, INC. A091001
    2 VANISH POINT SYRINGE, 3CC 25GX5/8" SYRINGE MEG RETRACTABLE TECHNOLOGIES, INC. A090905

    Patients

    Seq Age Sex Outcome Treatment
    1