BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET

    MDR report key: 25121335 · Received May 8, 2026

    Report

    Report Number
    3003442380-2026-15960
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Date of Event
    April 3, 2026
    Report Date
    April 8, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A DE C.V
    Product Code
    FPA
    UDI-DI
    05705244016651
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 802154. MANUFACTURING SITE: 3003442380.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT FACED ABSORPTION ISSUES WITH THREE INFUSION SET ON (B)(6) 2026. THE INFUSION SET WAS IN USE FOR LESS THAN ONE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223201 INSET SET, ADMINISTRATION, INTRAVASCULAR FPA UNOMEDICAL DEVICES S.A DE C.V 1001681 6013918 05705244016651

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female