BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 19111310 · Received April 15, 2024

    Report

    Report Number
    3005798905-2024-03177
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Date of Event
    April 15, 2024
    Report Date
    April 15, 2024
    Manufacturer
    FEEL TECH BIO 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 LOT 64232A WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 64232A. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.

    Additional Manufacturer Narrative · 0

    RETAINED LOT SAMPLES FOR SYRINGE LOT 64232A WERE TESTED FOR CANNULA BONDING FORCE. NO ABNORMALITIES WERE FOUND DURING TESTING.

    Description of Event or Problem · 0

    USER STATES WHILE PULLING INSULIN THE NEEDLE DEPLUGGED FROM THE BARREL AND STAYED IN THE BOTTLE. USER WAS ABLE TO PULL OUT NEEDLE OUT OF THE INSULIN VIAL.

    Description of Event or Problem · 0

    USER STATES WHILE PULLING INSULIN THE NEEDLE DEPLUGGED FROM THE BARREL AND STAYED IN THE BOTTLE. USER WAS ABLE TO PULL OUT NEEDLE OUT OF THE INSULIN VIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023387 EASYTOUCH SYRINGE FMF FEEL TECH BIO CO., LTD. 64232A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown