BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANISH POINT TUBERCULIN SYRINGE

    MDR report key: 11595033 · Received March 30, 2021

    Report

    Report Number
    MW5100359
    Event Type
    Malfunction
    Date Received
    March 30, 2021
    Date of Event
    March 25, 2021
    Report Date
    March 26, 2021
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    [VANISH POINT TUBERCULIN SYRINGE] TREATMENT UNDER EMERGENCY USE AUTHORIZATION (EUA): SYRINGE + NEEDLE DEFECTIVE. NOTICED AFTER PACKAGING WAS OPENED. APPEARS TO BE MELTED. LOT#G200915, EXP 8/28/2025. NO PATIENT HARM DONE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489936 VANISH POINT TUBERCULIN SYRINGE SYRINGE, ANTISTICK MEG RETRACTABLE TECHNOLOGIES, INC. G200915

    Patients

    Seq Age Sex Outcome Treatment
    1