BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET

    MDR report key: 23766104 · Received December 10, 2025

    Report

    Report Number
    3003442380-2025-17317
    Event Type
    Injury
    Date Received
    December 10, 2025
    Date of Event
    November 15, 2025
    Report Date
    February 5, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244022386
    PMA / PMN Number
    K032854
    Adverse Event
    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-JAN-2026 AGAINST "LOT NUMBER 6013542 AND SIMILAR MALFUNCTION CODS: SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - BLOCKAGE, SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE, SOFT CANNULA FOUND KINKED 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, THE REVIEW CONFIRMED THAT LOT 6013542 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NCRS OR CORRECTIVE AND PREVENTIVE ACTION (CAPA)S OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 13-JAN-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL 6013542 AND SIMILAR MALFUNCTION CODES SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - BLOCKAGE, SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE, SOFT CANNULA FOUND KINKED 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, THE COUNT OF COMPLAINT IS 1. THE COMPLAINT NUMBERS ARE COMPLAINT (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013542 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 79AND MANUFACTURED IN THE LINE 03, ON 07-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. IN THE TEST 24 ON 1 SET WITH NEEDLE DETACHED IN THE CONNECTOR. NO RELATION WITH MALFUNCTION. THEREFORE, THE OVERALL REVIEW OF THE DHR CONFIRMS THAT ALL REQUIRED PROCESS-RELATED TESTS WERE COMPLETED AND MET THE APPLICABLE REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED IN RELATION TO THE COMPLAINT CODE. CONCLUSION: DHR REVIEW IDENTIFIED MINOR FINDINGS. THEY WERE MANAGED ACCORDING TO PROCEDURE AND DID NOT IMPACT COMPLIANCE; NO ISSUES NOTED. 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 1 AIR FLOW TEST FOR COMPLAINTS AREA VERSION 2: ALL 3 SAMPLES TESTED PASSED FUNCTIONAL TESTING FOR THE REPORTED MALFUNCTION CODE SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - BLOCKAGE. ALL TEST RESULTS WERE WITHIN SPECIFICATION AS DOCUMENTED IN THE ATTACHED TEST REPORT COMPLAINT (B)(4). CONCLUSION: TESTING DID NOT CONFIRM THE REPORTED ISSUE; NO NONCONFORMANCE IDENTIFIED. 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: AS A RESULT OF THE FOLLOWING 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 6013542 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. SAMPLES WERE REQUESTED; HOWEVER, THE CUSTOMER CONFIRMED THAT NO SAMPLES 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 OCCURED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED THE INFUSION SET BENT CANNULA EVENT ON (B)(6) 2025. THE PATIENT NOTICED SYMPTOMS THREE OR MORE HOURS AFTER INSERTION AND THE SET WAS IN USE FOR 1.5 DAYS. THE SITE OF INSERTION WAS ABDOMEN. THE PATIENT EVENTUALLY WENT TO AN EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE LEVELS AND WAS SUBSEQUENTLY HOSPITALIZED ON (B)(6) 2025. THE PATIENT LATER SHIFTED TO THE INTENSIVE CARE UNIT WITH POSITIVE KETONES. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE 928 MG/DL AND THE PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN. THE PATIENT WAS ADMITTED FOR THREE DAYS, RELEASED ON (B)(6) 2025. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. 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
    2877131 INSET UNO INSET I 12/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1006922 6013542 05705244022386

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Hospitalization| R