BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 18178582 · Received November 20, 2023

    Report

    Report Number
    3005798905-2023-03147
    Event Type
    Malfunction
    Date Received
    November 20, 2023
    Date of Event
    November 1, 2023
    Report Date
    November 20, 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

    CMO INSPECTED RETAINED LOT 58196A, NO ABNORMALITIES WERE FOUND DURING TESTING.

    Additional Manufacturer Narrative · 0

    INITIAL TREND ANALYSIS FOR LOTS 59693 AND 58196A WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOTS 59693 AND 58196A. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.

    Description of Event or Problem · 0

    END USER REPORTS THAT THE CANNULAS ON SYRINGE LOTS 59693 EXPIRATION DATE 04/09/20207 AND 58196A EXPIRATION DATE 01/18/2027 HAVE BURRS AND THE NEEDLE IS CATCHING THE SKIN CAUSING THEM PAIN. USER ALSO REPORTS THAT THE PLUNGER IS EASILY REMOVED FROM THE BARREL.

    Description of Event or Problem · 0

    END USER REPORTS THAT THE CANNULAS ON SYRINGE LOTS 59693 EXPIRATION DATE 04/09/20207 AND 58196A EXPIRATION DATE 01/18/2027 HAVE BURRS AND THE NEEDLE IS CATCHING THE SKIN CAUSING THEM PAIN. USER ALSO REPORTS THAT THE PLUNGER IS EASILY REMOVED FROM THE BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1578437 EASYTOUCH INSULIN SYRINGE FMF BERPU MEDICAL TECHNOLOGY CO., LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown