BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET II

    MDR report key: 23388337 · Received October 27, 2025

    Report

    Report Number
    3003442380-2025-15348
    Event Type
    Injury
    Date Received
    October 27, 2025
    Date of Event
    September 21, 2025
    Report Date
    October 22, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018129
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2025-15348. CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED 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 UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6011953, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. TEST RESULTS: THE REFERENCE SAMPLES FOR THE LOT 6011953 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE COMPLAINT (B)(4) ON 18-OCT-2025. NO PHOTO WAS PROVIDED. IN ORDER TO TEST THE PRODUCT, THE RETURNED SAMPLE FROM THE LOT HAVE BEEN REQUESTED. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH: WI GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3: 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST AND WI GUIDANCE FOR FUNCTIONAL FLOW TESTING FOR COMPLAINTS AREA VERSION 2: 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST FOR THE CODE SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT (B)(4). THRESHOLD ANALYSIS: A QUERY WAS RUN ON 22-OCT-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL "6011953". THE COUNT OF COMPLAINT IS 2 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011953 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 121 AND MANUFACTURED IN THE LINE L4 LI39 ON 06-MAR-2025, 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 DEFECT ON TESTS FOR SAMPLES, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, TWO COMPLAINTS THRESHOLDS IDENTIFIED FOR THE LOT IN QUESTION AND SERIOUS INJURY/DEATH, 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.

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL (B)(4) - DEVICE 1 OF 2.

    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 CANADA. IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET CANNULA KINKED EVENT ON (B)(6) 2025. THE PATIENT FACED THIS ISSUE WITH 2 SETS. THE INSERTION SITE WAS ABDOMEN. THE SYMPTOMS OCCURRED WITHIN 3 OR MORE HOURS OF INSERTION. THE INFUSION SET WAS IN USE FOR 2 DAYS. THE BLOOD GLUCOSE LEVEL WAS OVER 33 MMOL/L AT THE TIME OF THE EVENT. THE PATIENT VISITED EMERGENCY ROOM ON (B)(6) 2025 AND WAS THERE FOR 5 HOURS. THE PATIENT GOT TREATED WITH IV AND FLUIDS OF SALINE AND INSULIN. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2793496 INSET II UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002817 6011953 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Female Required Intervention