BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET 30

    MDR report key: 24288956 · Received February 9, 2026

    Report

    Report Number
    3003442380-2026-00468
    Event Type
    Malfunction
    Date Received
    February 9, 2026
    Date of Event
    December 25, 2025
    Report Date
    January 23, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018365
    PMA / PMN Number
    K061374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4), DEVICE 5 OF 11.

    Description of Event or Problem · 0

    REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT EXPERIENCED INFUSION SETS TUBING DETACHMENT EVENTS ON 22-JAN-2026, 16-JAN-2026, 07-JAN-2026, 29-DEC-2025, 25-DEC-2025, 19-DEC-2025, 04-DEC-2025, 23-NOV-2025, 11-NOV-2025, 08-NOV-2025, 30-OCT-2025. THE INFUSION SET WAS IN USE FOR TWO DAYS. THE SITE OF DETACHMENT WAS TUBING CONNECTOR. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351031 INSET 30 UNO INSET 30 60/13 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002825 6014153 05705244018365

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male