BEUDAMED
    FDA Adverse Event Other Summary report: N

    U-100 SAFETY LOK

    MDR report key: 597102 · Received April 18, 2005

    Report

    Report Number
    597102
    Event Type
    Other
    Date Received
    April 18, 2005
    Date of Event
    March 30, 2005
    Report Date
    April 18, 2005
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC
    Product Code
    FMF
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    AT ONSET OF INJECTING AN INSULIN DOSE, THE SAFETY DEVICE PARTIALLY AND IMPROPERLY DEPLOYED RESULTING IN AN UNKNOWN AMOUNT OF INSULIN BEING INJECTED. SUBSEQUENTLY, THE NEEDLE NEVER DID RETRACT AND THE INSULIN APPEARS TO HAVE SOMEHOW BEEN PULLED BEYOND THE STOPPER INTO THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U-100 SAFETY LOK INSULIN SYRINGE FMF RETRACTABLE TECHNOLOGIES, INC 329464 *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR