BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRACTABLE TECHNOLOGIES INC.

    MDR report key: 302201 · Received October 26, 2000

    Report

    Report Number
    MW1020267
    Event Type
    Malfunction
    Date Received
    October 26, 2000
    Report Date
    October 26, 2000
    Manufacturer
    RETRACTABLE TECHNOLOGIES INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WAS IN THE PROCESS OF DRAWING UP THYPHOID WITH A 3CC VANISHPOINT SYRINGE 25GX1" RETRACTABLE NEEDLE, ONCE FINISHED DRAWING UP 1CC OF THYPHOID, ATTEMPTED TO REMOVE NEEDLE FROM RUBBER STOPPER WHEN THE NEEDLE SEPARATED FROM HUB OF SYRINGE THAT LEFT APPROX 75% OF THE NEEDLE INSIDE OF BOTTLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETRACTABLE TECHNOLOGIES INC. 3CC VANISHPOINT SYRINGE 25GX1CC FMF RETRACTABLE TECHNOLOGIES INC. * A190A

    Patients

    Seq Age Sex Outcome Treatment
    1 *