BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET II

    MDR report key: 23507820 · Received November 10, 2025

    Report

    Report Number
    3003442380-2025-15955
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    March 25, 2025
    Report Date
    November 28, 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
    MX
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4. 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. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED TO REVIEW THE DEVICE HISTORY RECORD (DHR) ASSOCIATED WITH THE REPORTED ISSUE. THE BATCH 6010638, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010638 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 75 IN THE LINE INSET 6, ON 06/DEC/2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING THE LOT 4L05378 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 65 AND MANUFACTURED IN THE MACHINE SC02, ON 05/DIC/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4L05379 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 65 AND MANUFACTURED IN THE MACHINE SC02, ON 06/DIC/2024, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (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. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION AND MALFUNCTION CODE, 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 MEXICO. IT WAS REPORTED THAT THE PATIENT FACED TWO INFUSION SET LEAKAGE EVENT BY UPPER MEMBRANE. ON (B)(6) 2025. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1848358 INSET II UNO INSET II 46/6 GREY Y-CAP 10PAK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 86-046-52B6 6010638

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown