BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANISH POINT TUBERCULIN SYRINGE

    MDR report key: 975929 · Received December 11, 2007

    Report

    Report Number
    975929
    Event Type
    Malfunction
    Date Received
    December 11, 2007
    Date of Event
    December 10, 2007
    Report Date
    December 11, 2007
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    WHEN TRYING TO ADMINISTER VITAMIN K TO A NEWBORN WITH A VANISHING POINT TUBERCULIN SYRINGE, DISCOVERED PLUNGER RESISTANCE. WHEN IT DID BEGIN TO WORK, MEDICATION APPEARED ON OUTSIDE OF INJECTION SITE AND THE NEEDLE RETRACTED BEFORE MEDICATION WAS ADMINISTERED. MANUFACTURER RESPONSE FOR VANISH POINT TUBERCULIN SYRINGE 1CC 27GX1/2", VANISH POINT TUBERCULIN SYRINGE: 2 REPRESENTATIVES CAME AND PICKED UP THE DEVICE ALONG WITH 5 MORE PACKAGES FROM THE SAME LOT NUMBER AND TOOK THEM BACK FOR ANALYSIS. THEY ALSO SPOKE WITH CLINICAL STAFF REGARDING HOW THEY OPENED PACKAGING AND HOW SYRINGE WAS LOADED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANISH POINT TUBERCULIN SYRINGE SYRINGE, TB, SAFETY MEG RETRACTABLE TECHNOLOGIES, INC. REF 10131 13703 10130

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA NO OTHER THERAPIES| NO OTHER THERAPIES