BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 15477183 · Received September 24, 2022

    Report

    Report Number
    3005798905-2022-03078
    Event Type
    Malfunction
    Date Received
    September 24, 2022
    Date of Event
    August 30, 2022
    Report Date
    September 23, 2022
    Manufacturer
    MHC MEDICAL PRODUCTS, LLC
    Product Code
    FMI
    PMA / PMN Number
    K112789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DUE THE FEEDBACK OCCURRENCE IT WAS DETERMINED THAT TWO SITUATIONS CAN CAUSE WHAT MAY APPEAR AS CLOGGING. IF THE END USER ACCIDENTALLY CAUSES THE NEEDLE TUBE INSIDE THE PEN HUB TO BEND BEFORE THE PEN NEEDLE IS PROPERLY SECURED ONTO THE INSULIN PEN, THE INSULIN PATH IS OBSTRUCTED. ANOTHER OCCURRENCE COULD OCCUR IF THE NEEDLE TUBE DOES NOT PROPERLY MEET THE INSULIN RUBBER BARRIER. THIS CAN OCCUR DUE TO THE DIFFERENCE IN BRANDS AND THE THICKNESS OF THE RUBBER BARRIER ON THE INSULIN PENS, THE RUBBER BARRIER/STOPPER IS NOT COMPLETELY PIERCED THEREFORE, THE INSULIN WILL NOT FLOW FREELY. NO DEVICE MALFUNCTIONS FOUND DURING RESERVED LOT TESTING.

    Description of Event or Problem · 0

    END USER REPORTS CLOGGING WHILE USING PEN NEEDLES CATALOG #: 831361, LOT: 52997, EXPIRATION DATE: 01/07/2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435692 EASYTOUCH PEN NEEDLES FMI MHC MEDICAL PRODUCTS, LLC 52997

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown