BEUDAMED
    FDA Adverse Event Summary report: N

    VANISH POINT 1 ML SYRINGE

    MDR report key: 11790031 · Received May 6, 2021

    Report

    Report Number
    MW5101228
    Date Received
    May 6, 2021
    Date of Event
    May 1, 2021
    Report Date
    May 5, 2021
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Product Code
    MEG
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    UNKNOWN DEBRIS FOUND IN VANISHPOINT SYRINGE. ONE OF OUR VACCINATORS NOTICED A SMALL PIECE OF BLACK DEBRIS IN A VANISH POINT 1 ML SYRINGE. SHE CAUGHT IT BEFORE ADMINISTERING THE DOSE, SO NO PT RECEIVED ANYTHING FROM THIS SYRINGE. SHE HAD JUST SWITCHED TO A NEW BOX, AND THE OLD BOX HAD MORE THAN ONE LOT NUMBER IN IT. SHE IS UNSURE WHICH LOT THE NEEDLE WAS FROM, AS SHE HAD ALREADY DISCARDED THE WRAPPER. THEREFORE, II MAY HAVE BEEN FROM ANY OF THE FOLLOWING THREE LOTS. G201215, G201211, G210117.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683565 VANISH POINT 1 ML SYRINGE SYRINGE, ANTISTICK MEG RETRACTABLE TECHNOLOGIES, INC. G201215G201211G21011

    Patients

    Seq Age Sex Outcome Treatment
    1