BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET II

    MDR report key: 24597032 · Received March 13, 2026

    Report

    Report Number
    3003442380-2026-02329
    Event Type
    Injury
    Date Received
    March 13, 2026
    Date of Event
    February 14, 2026
    Report Date
    March 14, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018303
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    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: COMPLAINT INVESTIGATION RESULTS: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 13/MAR/2026 AGAINST "LOT NUMBER" "6011730" AND SIMILAR MALFUNCTION CODES: SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL -BLOCKAGE, SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE, SOFT CANNULA FOUND CRIMPED UPON REMOVAL FROM INFUSION SITE, SOFT CANNULA AND INTRODUCER NEEDLE FOUND BENT/KINKED DURING INSERTION, UNABLE TO USE, SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE. THE REVIEW CONFIRMED THAT LOT 6011730 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NONCONFORMING REPORTS (NCRS) OR CORRECTIVE AND PREVENTIVE ACTION (CAPAS) OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 13/MAR/2026 AGAINST "LOT NUMBER" CRITERIA EQUAL "6011730" AND SIMILAR MALFUNCTION CODES: SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL -BLOCKAGE, SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE, SOFT CANNULA FOUND CRIMPED UPON REMOVAL FROM INFUSION SITE, SOFT CANNULA AND INTRODUCER NEEDLE FOUND BENT/KINKED DURING INSERTION, UNABLE TO USE, SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE. THE COUNT OF COMPLAINT IS 1. THE COMPLAINT NUMBERS ARE (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011730 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 121 AND MANUFACTURED IN LINE 7, ON 03/MAR/2025 WITH A TOTAL OF (B)(4) UNITS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT ALL REQUIRED IN PROCESS INSPECTIONS AND FINAL PRODUCT TESTS WERE COMPLETED AS SPECIFIED. DURING OUTGOING TEST 6, ONE SAMPLE WAS IDENTIFIED WITH A CONTAMINATED LID; HOWEVER, AN EXTENDED SAMPLING WAS PERFORMED IN ACCORDANCE WITH ESTABLISHED PROCEDURES, AND ALL RESULTS MET THE APPLICABLE ACCEPTANCE CRITERIA. ADDITIONALLY, DURING THE DOCUMENTATION REVIEW, NON CONFORMANCE (NC) 2170006 WAS IDENTIFIED AND HAD BEEN OPENED DURING THE STERILIZATION PROCESS. APPROPRIATE ACTIONS WERE TAKEN AS PART OF THAT NON CONFORMANCE. CONCLUSION: THE DHR REVIEW SUPPORTS COMPLIANCE WITH MANUFACTURING AND QUALITY REQUIREMENTS. THE ISOLATED OUTGOING TEST 6 FINDING WAS PROPERLY ADDRESSED THROUGH EXTENDED SAMPLING WITH ACCEPTABLE RESULTS. FURTHERMORE, THE STERILIZATION RELATED NC 2170006 WAS MANAGED WITHIN THE ESTABLISHED QUALITY SYSTEM AND DOES NOT INDICATE AN ISSUE THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT. OVERALL, NO MANUFACTURING RELATED CONDITIONS WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. VISUAL EVIDENCE REVIEW: NO PHOTO WAS PROVIDED TO SUPPORT VISUAL CONFIRMATION OF THE REPORTED ISSUE. CONCLUSION: UNABLE TO PERFORM VISUAL VERIFICATION; ASSESSMENT BASED ON AVAILABLE DOCUMENTATION ONLY. RETAIN SAMPLES TESTING: RETAIN SAMPLES FROM THE RELEVANT LOT WERE REQUESTED AND TESTED IN ACCORDANCE WITH APPROVED PROCEDURES: WI - GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA (VERSION 3): ALL 3 SAMPLES TESTED PASSED VISUAL INSPECTION. WI - GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA (VERSION 2): ALL 3 SAMPLES TESTED PASSED FUNCTIONAL AIR FLOW TESTING FOR THE REPORTED MALFUNCTION CODE SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL-BLOCKAGE. CONCLUSION: TESTING DID NOT CONFIRM THE REPORTED ISSUE; NO NONCONFORMANCE IDENTIFIED. CAPA DETERMINATION ASSESSMENT - CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: BASED ON THE INVESTIGATION, NO FURTHER INVESTIGATION IS REQUIRED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH TRACKING AND TRENDING PER WI (MONTHLY TRIPS AND ALERTS). CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: A COMPREHENSIVE REVIEW WAS CONDUCTED, INCLUDING EQMS QUERIES, SIMILAR COMPLAINT SEARCHES, DEVICE HISTORY RECORD REVIEW, VISUAL EVIDENCE ASSESSMENT, AND CAPA DETERMINATION. NO NCRS OR CAPAS OF THE SAME OR SIMILAR NATURE WERE FOUND FOR LOT 6011730 AND RELATED MALFUNCTION CODES. ONE COMPLAINT WAS IDENTIFIED FOR THIS LOT; HOWEVER, NO TREND OR SYSTEMIC ISSUE WAS DETECTED. THE MANUFACTURING RECORDS CONFIRMED THAT THE LOT WAS PRODUCED IN COMPLIANCE WITH ALL REQUIREMENTS, WITH NO DEVIATIONS OR MAINTENANCE EVENTS NOTED. PHOTOS WERE REQUESTED; HOWEVER, THE CUSTOMER CONFIRMED THAT NO PHOTOS WERE AVAILABLE FOR ANALYSIS. CONSEQUENTLY, AN INVESTIGATION WAS CONDUCTED USING REFERENCE SAMPLES, AND NO FAILURES RELATED TO THE COMPLAINT WERE IDENTIFIED. NO PHOTO EVIDENCE WAS PROVIDED, SO THE ASSESSMENT WAS BASED ON DOCUMENTATION AND REFERENCE SAMPLE ANALYSIS ONLY. BASED ON THESE RESULTS, NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH ROUTINE TRACKING AND TRENDING.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN ITALY. IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND EVENTUALLY GOT HOSPITALIZED DUE TO HYPERGLYCEMIA EVENT ON (B)(6) 2026. PATIENT REPORTED OCCLUSION ALARM CAUSED BY THE BENT CANNULA AND PUMP ISSUE. THE BLOOD GLUCOSE LEVEL WAS 288 MG/DL AND THE PATIENT WAS TREATED WITH INTRAVENOUS (IV) AND FLUIDS. PATIENT FOUND POSITIVE FOR KETONES AND LEVELS ARE HIGH AND LIFE THREATENING. PATIENT RELEASED FROM THE HOSPITAL ON (B)(6) 2026. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655687 INSET II UNO INSET II 60/6 BLUE TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002823 6011730 05705244018303

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H| L