BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 17600374 · Received August 22, 2023

    Report

    Report Number
    3005798905-2023-03132
    Event Type
    Malfunction
    Date Received
    August 22, 2023
    Date of Event
    August 21, 2023
    Report Date
    August 22, 2023
    Manufacturer
    BERPU MEDICAL TECHNOLOGY CO., LTD
    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

    INITIAL TREND ANALYSIS FOR LOTS 60717, 58185, 57076, 57065 WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 60717, 58185, 57076, 57065. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.

    Description of Event or Problem · 0

    END USER REPORTS DISCREPANCIES BETWEEN THE DIFFERENT FACILITIES THAT MANUFACTURE THE EASYTOUCH SYRINGES. THE USER REPORTS THAT LOTS 60717 EXP DATE 04/02/2028, LOT 58185 EXP DATE 01/21/2027, LOT 57076 EXP DATE 10/29/2026 AND LOT 57065 EXP 11/15/2026 APPEAR TO HAVE DIFFERENT COLORING ON THE POLYBAGS, THE FINGER GRIPS ARE LARGER, THE SYRINGE BARRELS ARE BOWED AND THE SCARCITY OF LUBRICATION IN THE SYRINGE BARREL MAKES IT DIFFICULT TO ADMINISTER THE FULL AMOUNT OF INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524841 EASYTOUCH SYRINGE FMF BERPU MEDICAL TECHNOLOGY CO., LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown