BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANISHPOINT SYRINGE

    MDR report key: 1810751 · Received August 16, 2010

    Report

    Report Number
    MW5017125
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 16, 2010
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS RELATES TO THE VANISH POINT 3.0CC SYRINGE. SYRINGE LOT NUMBER A901204, (B)(4), BARCODE ON THE SYRINGE WRAPPER 13703 10390. A SUPPOSEDLY STERILE SYRINGE THAT CONTAINED FOREIGN MATTER. OUR NURSE OPENED A FRESH, UNUSED SYRINGE PACKAGE, PUNCTURED THE RUBBER CAP OF A VACCINE VIAL, INSERTED THE VANISHPOINT SYRINGE NEEDLE INTO THE VIAL, BEGAN TO DRAW THE VACCINE LIQUID INTO THE SYRINGE, AND AT THAT POINT NOTICED A DARK HAIR OF ABOUT 1 CM IN LENGTH ON THE INSIDE OF THE BARREL OF THE SYRINGE. THERE WAS NO ADVERSE EVENT TO THE PATIENT, AS THIS SYRINGE WAS NOT USED FOR THE INJECTION. WE HAVE RETAINED THE SYRINGE AND ITS ORIGINAL PACKAGING WRAPPER IN CASE THERE ARE FURTHER QUESTIONS. DATES OF USE: (B)(6) 2010 -- (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: VACCINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANISHPOINT SYRINGE VANISHPOINT SYRINGE 3.0 CC MEG RETRACTABLE TECHNOLOGIES, INC. REF 10391 A091204

    Patients

    Seq Age Sex Outcome Treatment
    1 MENACTRA VACCINE -HOWEVER THE INJECTION WAS NEVER| GIVEN TO THE PATIENT-.