BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANISHPOINT SYRINGE 5/8" GAUGE

    MDR report key: 3231338 · Received July 12, 2013

    Report

    Report Number
    MW5030905
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 10, 2013
    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

    RN WAS USING THE SYRINGE TO RECONSTITUTE YELLOW FEVER VACCINE. SHE WITHDREW THE DILUENT FROM ONE VIAL AND INJECTED IT INTO THE VIAL CONTAINING THE LYOPHILIZED YELLOW FEVER VACCINE, MIXING THE LIQUID AND DRY INGREDIENTS TOGETHER. SHE THEN DREW UP THE VACCINE INTO THE BARREL OF THE SYRINGE AND WHEN SHE ATTEMPTED TO REMOVE THE SYRINGE WITH NEEDLE FROM THE VIAL THE NEEDLE DETACHED FROM THE BARREL OF THE SYRINGE. IF THIS HAD OCCURRED WHEN THE NEEDLE WAS IN THE ARM OF A PT IT COULD HAVE CAUSED SERIOUS INJURY. ONE DOSE OF YELLOW FEVER WAS WASTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323719 VANISHPOINT SYRINGE 5/8" GAUGE SAFETY SYRINGE MEG RETRACTABLE TECHNOLOGIES, INC. REF 10391 A120810

    Patients

    Seq Age Sex Outcome Treatment
    1