BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANISHPOINT SYRINGE

    MDR report key: 11957101 · Received June 7, 2021

    Report

    Report Number
    MW5101747
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    June 2, 2021
    Report Date
    June 4, 2021
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAFF DREW UP MEDICATION TO ADMINISTER USING A VANISHPOINT SYRINGE AND WHEN ATTEMPTING TO ADMINISTER MEDICATION TO PATIENT THE PLUNGER WOULD NOT DEPRESS ALLOWING THE MEDICATION TO BE ADMINISTERED. STAFF NEEDED TO GET NEW NEEDLE AND SYRINGE TO ADMINISTER MEDICATION TO PATIENT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841303 VANISHPOINT SYRINGE SYRINGE, ANTISTICK MEG RETRACTABLE TECHNOLOGIES, INC. 3ML 25G X 5/8" NEEDLE A887A

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR