BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 16449232 · Received February 27, 2023

    Report

    Report Number
    3005798905-2023-03102
    Event Type
    Malfunction
    Date Received
    February 27, 2023
    Date of Event
    February 24, 2023
    Report Date
    February 27, 2023
    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

    INITIAL TREND ANALYSIS FOR LOT 59322 WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 59322. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE WAS RETURNED AND TESTED FOR ANY IRREGULARITIES. THE RETURNED THE TESTING RESULTS ON 4-27-2023, RESULTS AS FOLLOWS; NO NON-CONFORMITIES FOUND DURING TESTING. NO LEAKING WAS FOUND DURING SIMULATION TESTS.

    Description of Event or Problem · 0

    END USER REPORTS THAT WHILE USING PN ITEM NUMBER 831061 LOT 59322 EXPIRATION DATE 04/12/2027 WITH LANTUS INSULIN PEN, THE INSULIN LEAKS FROM THE BETWEEN THE PEN NEEDLE HUB AND THE CANNULA DURING HER INJECTION.

    Description of Event or Problem · 0

    END USER REPORTS THAT WHILE USING PN ITEM NUMBER 831061 LOT 59322 EXPIRATION DATE 04/12/2027 WITH LANTUS INSULIN PEN, THE INSULIN LEAKS FROM THE BETWEEN THE PEN NEEDLE HUB AND THE CANNULA DURING HER INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384981 EASYTOUCH PEN NEEDLE FMI MHC MEDICAL PRODUCTS, LLC 59322

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown