BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET

    MDR report key: 24090633 · Received January 15, 2026

    Report

    Report Number
    3003442380-2025-19123
    Event Type
    Injury
    Date Received
    January 15, 2026
    Date of Event
    December 20, 2025
    Report Date
    March 14, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244016620
    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

    INITIAL AND FINAL MDR (B)(4) DEVICE 2 OF 3.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 (B)(4) MDR 3003442380-2025-19123. THE INITIAL MDR WITH MANUFACTURING REPORT NUMBER (3003442380-2025-19122), WAS SUBMITTED ON 15-JAN-2026. UPON COMPLETION OF THE INVESTIGATION, THE MANUFACTURING DATE WAS UPDATED AS 02-SEP-2023. 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 03-MAR-2026 AGAINST "LOT NUMBER 6002865 AND SIMILAR MALFUNCTION CODE(S): 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 6002865 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANYY 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 03-MAR-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL 6002865 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 COMPLAINTS IS 15. THE COMPLAINT NUMBERS ARE (B)(4). CONCLUSION: AFTER REVIEW, ONLY (B)(4) WAS DETERMINED RELEVANT TO THE REPORTED ISSUE. THE OTHER TWELVE RECORDS WERE PREVIOUSLY CLOSED AND ARE NOT APPLICABLE TO THIS INVESTIGATION. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6002865 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 106 AND MANUFACTURED IN THE INSET L3 ON 02/SEP/2023 WITH A TOTAL OF (B)(4) UNITS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED IN ACCORDANCE WITH APPLICABLE PROCEDURES, AND ONE NON-CONFORMANCE (NC) 1741191 WAS RAISED DURING STERILIZATION PROCESS (THIS ISSUE IS RELATED TO CLEAN ROOM ENVIRONMENT WHICH IS NOT LINKED TO THE DESIGN ASPECTS OF THE PRODUCT.). AND IT IS NOT ASSOCIATED TO THE REPORTED ISSUE ON THIS COMPLAINT. 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 SUPPORTS COMPLIANCE WITH MANUFACTURING AND QUALITY REQUIREMENTS; 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. 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). CAPA DETERMINATION RESULTS: THIS COMPLAINT FALLS UNDER THE SCOPE OF THE CAPA 1768101: "AUTOSOFT 90, KINKED SOFT CANNULA ISSUES" AND WILL COVER INSET I (AUTOSOFT XC DHF-13.8 & 13.13) AND INSET II (AUTOSOFT 90 DHF-14 AND 14.3) PRODUCTS. ROOT CAUSE OF PROBLEM: THE ROOT CAUSE HAS BEEN IDENTIFIED AS: METHOD, MANPOWER, MEASUREMENT, MACHINE: CORRECTIVE ACTION AS A RESULT OF THE INVESTIGATION: THE ACTION PLAN AND DEADLINES IS AS FOLLOWED: THE FOLLOWING ACTIONS WERE ALREADY IMPLEMENTED IN THE NC. 1. INCLUDE THE DEFECT IN DOCUMENT (WORK INSTRUCTION INSET LINE). 2. IMPROVE GUARDS OF THE CONVEYORS. 3. UPDATE TRAYS FOR THE STOCK OF CANNULAS. 4. UPDATE DOCUMENT (QUALITY SPECIFICATION FOR CATHETER FIXTURE FOR SKEWED CATHETERS) FOR INCLUDE THE HANDLING OF THE CATHETER DURING THE PROCESS. 5. UPDATE THE DOCUMENT (WORK INSTRUCTION INSET LINE) TO INCLUDE THE PREVENTIVE ACTIONS IMPLEMENTED IN THE PROCESS (TRAYS) A REMAINING ACTION (TO ADDRESS DESIGN ROOT CAUSE) AND DEADLINES IS AS FOLLOWED: ADD CYLINDERS TO THE LID TO MAINTAIN IN POSITION THE NEEDLE AND CANNULA DURING TRANSPORTATION AND PRIOR USE (DATABASE 1771074- 30/SEP/2025). 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. ONE NC OF THE SAME OR SIMILAR NATURE WAS FOUND FOR LOT 6002865 AND RELATED MALFUNCTION CODES FOR SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - BLOCKAGE. FIFTEEN COMPLAINTS WERE IDENTIFIED FOR THIS LOT, BUT 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. NO PHOTO EVIDENCE WAS PROVIDED, SO THE ASSESSMENT WAS BASED ON DOCUMENTATION ONLY. BASED ON THESE RESULTS, NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED, AND NO FURTHER INVESTIGATION IS REQUIRED. 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 THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED THREE BENT CANNULA ISUUES AND WENT TO AN EMERGENCY ROOM (ER) AND EVENTUALLY GOT HOSPITALIZED ON (B)(6) 2025 DUE TO HYPERGLYCEMIA. THE EVENT OCCURRED AFTER THREE OR MORE HOURS OF INSERTION. THE INSERTION SITE WAS THE UPPER BUTTOCKS. THE BLOOD GLUCOSE LEVEL WAS HIGH AND THE PATIENT GOT TREATED WITH INTRAVENOUS (IV) OF SALINE AND INSULIN. PATIENT WAS FOUND POSITIVE FOR KETONES LEVEL. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR SIX HOURS AND RELEASED ON (B)(6) 2025. 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
    568147 INSET UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1001680 6002865 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention