BEUDAMED
    FDA Adverse Event Other Summary report: N

    VANISHPOINT, 3CC SYRINGE

    MDR report key: 353708 · Received September 27, 2001

    Report

    Report Number
    MW1022950
    Event Type
    Other
    Date Received
    September 27, 2001
    Report Date
    September 24, 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

    INJECTIONS WERE PERFORMED WITH NEEDLES. WHEN BUTTON WAS PUSHED TO RETRACT THE NEEDLE, NEEDLE WOULD NOT RETRACT. WHEN NEEDLE WAS PULLED OUT, THE NEEDLE WAS BENT. THERE WERE TWO (2) INSTANCES OF THIS SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43811 VANISHPOINT, 3CC SYRINGE SYRINGE & NEEDLE HYPODERMIC, 3CC, 22GA, 1 1/2" FMF RETRACTABLE TECHNOLOGIES, INC. * A221A

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other