BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET II

    MDR report key: 23529294 · Received November 11, 2025

    Report

    Report Number
    3003442380-2025-16107
    Event Type
    Malfunction
    Date Received
    November 11, 2025
    Date of Event
    October 13, 2025
    Report Date
    January 1, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018181
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED BRAND NAME, COMMON DEVICE NAME UNDER D2 AND MODEL NUMBER, SERIAL NUMBER, PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) NUMBER UNDER D4. 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 6010361, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010361 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 120 IN THE LINE 6, ON 20/NOV/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. 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. THERE WERE ONE EXTENDED EVENT, DUE TO LOW TEMPERATURE IN HEATING AEREATION PHASE AT STERIGENICS G.P DURING STERILIZATION PROCESS, WHICH ARE NOT RELATED TO THE MALFUNCTION CODE. 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 FRANCE. IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET LEAKAGE EVENT ON (B)(6) 2025. THE LEAKAGE WAS AT THE CANNULA SITE AT THE INSERTION POINT OF TWO CATHETERS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2122047 INSET II UNO INSET II 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002819 6010361 05705244018181

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown