BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET II

    MDR report key: 23320557 · Received October 17, 2025

    Report

    Report Number
    3003442380-2025-15109
    Event Type
    Malfunction
    Date Received
    October 17, 2025
    Date of Event
    September 18, 2025
    Report Date
    October 7, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY - REVISION (B)(4) OF (B)(4) DOES NOT REQUIRE A COMPLAINT THAT IS TYPE 2 REPORTABLE TO OPEN A CHILD INVESTIGATION. THIS CHILD INVESTIGATION WAS OPENED AGAINST A PREVIOUS REVISION OF (B)(4). COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6010634, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010634 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 75 AND MANUFACTURED IN THE LINE L5 ON 06-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. GLUING TUBE THE LOT 4L06545 WAS MANUFACTURED ACCORDING TO THE WI VERSION 64 AND MANUFACTURED IN THE LINE SC09 ON 05-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. TEST RESULTS: PHOTO/SAMPLE WAS NOT PROVIDED. NO RETURNED SAMPLE WILL BE AVAILABLE FOR THIS COMPLAINT, AS INDICATED IN THE REPORT. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED, ONE NON-CONFORMANCE (NC) RAISED DURING PRODUCTION UNRELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED KINGDOM IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET KINKED TUBING EVENT ON (B)(6) 2025 NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2671302 INSET II UNO INSET II 60/6 GREY Y-CAP 10PAK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 86-060-52B6 6010634

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown