BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANISH POINT SYRINGE

    MDR report key: 11737105 · Received April 27, 2021

    Report

    Report Number
    MW5101007
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    March 11, 2021
    Report Date
    April 26, 2021
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    [RETRACTABLE TECHNOLOGIES INC 1 ML 25G VANISH POINT SYRINGE REF# 10162 FOR COVID VACCINE ADMINISTRATION] USE FOR COVID-19 UNDER EMERGENCY USE AUTHORIZATION (EUA): MED RECON NURSE NOTICED THE PLUNGER OF A NEW, UNUSED SYRINGE WAS LOPSIDED AFTER THE TAKING THE SYRINGE OUT OF THE WRAPPER. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626669 VANISH POINT SYRINGE SYRINGE, ANTISTICK MEG RETRACTABLE TECHNOLOGIES, INC. 10162 NA

    Patients

    Seq Age Sex Outcome Treatment
    1