BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANISH POINT

    MDR report key: 11628225 · Received April 6, 2021

    Report

    Report Number
    MW5100594
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    April 2, 2021
    Report Date
    April 3, 2021
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    117

    Narratives

    Description of Event or Problem · 1

    WHEN PUSHING THE PLUNGER TO ADMINISTER PFIZER VACCINE, THE NEEDLE RETRACTED FROM THE LEFT DELTOID CAUSING THE VACCINE TO RUN DOWN THE PATIENT'S ARM. IT WAS A VANISH POINT SYRINGE, LOT # G201122, EXP DATE 10-28-2025. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522981 VANISH POINT SYRINGE, ANTISTICK MEG RETRACTABLE TECHNOLOGIES, INC. G201122

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR