BEUDAMED
    FDA Adverse Event Other Summary report: N

    VANISHPOINT, 3CC SYRINGE

    MDR report key: 353715 · Received September 27, 2001

    Report

    Report Number
    MW1022951
    Event Type
    Other
    Date Received
    September 27, 2001
    Report Date
    September 27, 2001
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Product Code
    FMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS ITEM WAS USED TO GIVE AN INJECTION. PT COMPLAINED THAT IT FELT LIKE THE NEEDLE CAUGHT WHEN IT WAS INSERTED AND WHEN IT WAS WITHDRAWN. THE PLUNGER WAS COMPLETELY DEPRESSED AND THE SAFETY MECHANISM DID NOT TRIGGER (NEEDLE DID NOT RETRACT INTO SAFE POSITION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43824 VANISHPOINT, 3CC SYRINGE SYRINGE & NEEDLE HYPODERMIC 3CC, 23GA, 1" FMF RETRACTABLE TECHNOLOGIES, INC. * RTA068A

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other