BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETRACTABLE TECHNOLOGIES, INC.

    MDR report key: 536852 · Received June 7, 2004

    Report

    Report Number
    MW1032325
    Event Type
    Injury
    Date Received
    June 7, 2004
    Date of Event
    June 6, 2004
    Report Date
    June 6, 2004
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ALL OF THIS TYPE OF VANISHING POINT INSULIN SYRINGES ARE FLAWED AND DIFFICULT TO USE TO ACCURATELY MEASURE INSULIN. DESPITE MULTIPLE TECHNIQUE ADJUSTMENTS AND ATTEMPTS TO FLICK AND EXPEL AIR FROM SYRINGE, IT IS NEAR IMPOSSIBLE TO ELIMINATE AN AIR BUBBLE FROM SYRINGE. THEREFORE, PTS MAY NOT RECEIVE ACCURATE DOSAGES WHEN ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETRACTABLE TECHNOLOGIES, INC. VANISHING POINT INSULIN SYRINGE FMF RETRACTABLE TECHNOLOGIES, INC. REF 10211 F098A

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention