BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANISH POINT SYRINGE

    MDR report key: 372204 · Received January 9, 2002

    Report

    Report Number
    372204
    Event Type
    Injury
    Date Received
    January 9, 2002
    Date of Event
    December 16, 2001
    Report Date
    January 7, 2002
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADMINISTERED INSULIN WITH A U-100 1ML INSULIN SYRINGE WITH A 29G X 1.5" NEEDLE. THE NURSE INJECTED THE RESIDENT WITH INSULIN AND AFTER COMPLETION OF THE DOSE. APPLIED PRESSURE TO THE PLUNGER OF THE SYRINGE TO ACTIVATE THE NEEDLE RETRACTING MECHANISM. THE NURSE WAS NOT AWARE THAT THE RETRACTION MECHANISM FAILED TO FUNCTION. THE NURSE SUSTAINED A NEEDLE STICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANISH POINT SYRINGE SYRINGE WITH RETRACTABLE NEEDLE. INSULIN U-100 FMF RETRACTABLE TECHNOLOGIES, INC. * F026A

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention