BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 20076208 · Received August 27, 2024

    Report

    Report Number
    3005798905-2024-03199
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    July 1, 2024
    Report Date
    August 26, 2024
    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 LOTS 67021 AND 66807, NO ABNORMALITIES WERE FOUND DURING TESTING.

    Description of Event or Problem · 0

    A REPRESENTATIVE FROM A DIRECT CUSTOMER WAS CONTACTED BY A CUSTOMER OF THEIRS REPORTING THAT CANNULAS ARE BREAKING FROM TWO ITEMS 830365 LOT 67021 AND 830565 LOT 66807.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968969 EASYTOUCH SYRINGE FMF BERPU MEDICAL TECHNOLOGY CO., LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown