BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 18695313 · Received February 13, 2024

    Report

    Report Number
    3005798905-2024-03164
    Event Type
    Malfunction
    Date Received
    February 13, 2024
    Date of Event
    February 8, 2024
    Report Date
    February 13, 2024
    Manufacturer
    FEEL TECH BIO CO., LTD.
    Product Code
    FMF
    PMA / PMN Number
    K102178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINED LOT SAMPLES FOR SYRINGE LOT 65521A WERE TESTED FOR NEEDLE SHARPNESS, NO ABNORMALITIES WERE FOUND DURING TESTING.

    Additional Manufacturer Narrative · 0

    INITIAL TREND ANALYSIS FOR LOTS 55052A AND 65521A WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOTS 55052A AND 65521A. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.

    Description of Event or Problem · 0

    END USER REPORTED TO A DIRECT CUSTOMER THAT WHILE USING ITEM (B)(4) LOT 65521A CANNULA IS BURRED, FLIMSY AND ON ONE ACCOUNT THE CANNULA BROKE OFF. THIS USER WAS SENT REPLACEMENTS BY THE DIRECT CUSTOMER ITEM 831165 LOT 55052A, FOLLOWING UP THAT THE CANNULAS ON THIS LOT WERE ALSO FLIMSY AND BURRED. USER REPORTS THAT CANNULA BREAKING OFF AT THE TIP AS WELL AS NEAR THE HUB.

    Description of Event or Problem · 0

    END USER REPORTED TO A DIRECT CUSTOMER THAT WHILE USING ITEM 831165 LOT 65521A CANNULA IS BURRED, FLIMSY AND ON ONE ACCOUNT THE CANNULA BROKE OFF. THIS USER WAS SENT REPLACEMENTS BY THE DIRECT CUSTOMER ITEM 831165 LOT 55052A, FOLLOWING UP THAT THE CANNULAS ON THIS LOT WERE ALSO FLIMSY AND BURRED. USER REPORTS THAT CANNULA BREAKING OFF AT THE TIP AS WELL AS NEAR THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2158638 EASYTOUCH SYRINGE FMF FEEL TECH BIO CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown