BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASY TOUCH

    MDR report key: 14522645 · Received May 27, 2022

    Report

    Report Number
    3005798905-2022-03062
    Event Type
    Malfunction
    Date Received
    May 27, 2022
    Date of Event
    May 15, 2022
    Report Date
    May 27, 2022
    Manufacturer
    MHC MEDICAL PRODUCTS, LLC
    Product Code
    FMF
    PMA / PMN Number
    K102178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE WAS RETURNED FOR TESTING. RETAINED LOT NUMBER 54471, EXPIRATION DATE 08/10/2026 WAS INVESTIGATED. A TOLERANCE CAPACITY TEST FROM THE RESERVED SAMPLES RESULTED IN NO ABNORMALITY FOUND IN THE SAFETY SYRINGE FROM LOT 54471.

    Description of Event or Problem · 0

    A COMPLAINT WAS RECEIVED VIA EMAIL FROM THE (B)(4) REGARDING A DOSAGE CONCERN OF ITEM 802015, LOT 54471 EXPIRATION DATE 08/10/2026 WHEN USED WITH THE COVID-19 VACCINE. THIS COMPLAINT IS IN REGARDS TO THE SMALL RUBBER PIECE ON THE END OF THE PLUNGER INSIDE THE BARREL. THE USER'S REPORT THAT; "WHEN DRAWN UP TO .3MG AS DIRECTED, THE DOSAGE IS NOT .3 MG, IT IS LESS DUE TO THE EXTRA PLUNGER." ALSO, THE SHAPE OF THE PLUNGER IS CAUSING AN INACCURATE MEASUREMENT OF THE COVID-19 VACCINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711371 EASY TOUCH SAFETY SYRINGE LUER LOCK FMF MHC MEDICAL PRODUCTS, LLC 54471

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown