BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET II

    MDR report key: 24712595 · Received March 30, 2026

    Report

    Report Number
    3003442380-2026-99421
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    February 18, 2024
    Report Date
    February 25, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018181
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL (B)(4) - DEVICE 3 OF 3. UNOMEDICAL HEREBY SUBMITS THIS INITIAL REPORT AS PART OF ITS COMPLAINT REMEDIATION ACTIVITIES CONDUCTED UNDER A CORRECTIVE AND PREVENTIVE ACTION (CAPA)/FDA ACTION PLAN. THIS SUBMISSION INCLUDES A RETROSPECTIVE REASSESSMENT OF PREVIOUSLY EVALUATED COMPLAINTS. UNOMEDICAL IS PROVIDING THIS INITIAL INFORMATION IN ACCORDANCE WITH THE REPORTING REQUIREMENTS SET FORTH IN 21 CFR PART 803. ANY FIELDS LEFT BLANK INDICATE THAT THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR REMAINS UNCHANGED. BASED ON THE REVIEW COMPLETED ON 25-FEB-2026 AND INVESTIGATION COMPLETED ON 06-MAR-2026 THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED AS THE INITIAL REPORT. 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. THIS INVESTIGATION HAS BEEN UPDATED BECAUSE THE MALFUNCTION CODE CHANGED FROM LEAKAGE FROM INFUSION SITE (CANNULA BASE PART/CANNULA) (SPECIFIC CAUSE NOT IDENTIFIED) TO INSERTION SITE EGRESS - TRACE MOISTURE / SUPERFICIAL WETNESS, WHICH REQUIRES ADDITIONAL ACTIVITIES NOT INCLUDED IN THE ORIGINAL INVESTIGATION DATED 28-FEB 2024. THE ORIGINAL INVESTIGATION REMAINS VALID AND HAS NOT BEEN MODIFIED. AS PART OF THIS REASSESSMENT, THE FOLLOWING ELEMENTS WERE ADDED TO ALIGN WITH CURRENT INVESTIGATION REQUIREMENTS: COMPLAINT INVESTIGATION RESULTS: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 05/MAR/2026 AGAINST "LOT NUMBER" "6002531" AND SIMILAR MALFUNCTION CODES: LEAKAGE FROM INFUSION SITE (CANNULA BASE PART/CANNULA) (SPECIFIC CAUSE NOT IDENTIFIED), INSERTION SITE EGRESS - TRACE MOISTURE / SUPERFICIAL WETNESS. THE REVIEW CONFIRMED THAT LOT 6002531 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NON-CONFORMANCE REPORTS (NCRS) OR CORRECTIVE AND PREVENTIVE ACTION (CAPA) OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 05/MAR/2026 AGAINST "LOT NUMBER" CRITERIA EQUAL "6002531" AND SIMILAR MALFUNCTION CODES: LEAKAGE FROM INFUSION SITE (CANNULA BASE PART/CANNULA) (SPECIFIC CAUSE NOT IDENTIFIED), INSERTION SITE EGRESS - TRACE MOISTURE / SUPERFICIAL WETNESS. THE NUMBER OF COMPLAINTS IS 2. THE COMPLAINT NUMBERS ARE (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6002531 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION (WI) VERSION 106 AND MANUFACTURED IN THE LINE 4, ON 30/JUL/2023 WITH A TOTAL OF (B)(4) UNITS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED IN ACCORDANCE WITH APPLICABLE PROCEDURES. ALL REQUIRED IN-PROCESS AND FINAL TESTS WERE COMPLETED AND MET SPECIFIED REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED THAT RELATE 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. 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). FINAL CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: THE INVESTIGATION FOR THIS COMPLAINT WAS PREVIOUSLY COMPLETED ON 28-FEB 2024 UNDER CHILD COMPLAINT INVESTIGATION RECORD (B)(4). THE INVESTIGATION HAS BEEN REVISED TO REFLECT THE UPDATED MALFUNCTION CODE AND NEW REPORTABILITY REQUIREMENTS. THE ORIGINAL INVESTIGATION REMAINS VALID AND HAS NOT BEEN MODIFIED. AS PART OF THIS REASSESSMENT, AN UPDATED EQMS SEARCH WAS PERFORMED WHICH IDENTIFIED TWO RELATED COMPLAINTS FOR LOT 6002531. NO NCRS, CAPAS, TRENDS, OR SYSTEMIC ISSUES WERE FOUND. AS REQUIRED UNDER THE UPDATED REPORTABILITY CRITERIA, A FULL DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED. ALL IN PROCESS AND FINAL INSPECTIONS MET SPECIFICATION REQUIREMENTS, AND NO DEVIATIONS, REWORK ACTIVITIES, OR MAINTENANCE EVENTS ASSOCIATED WITH THE MALFUNCTION WERE IDENTIFIED. NO VISUAL EVIDENCE WAS AVAILABLE TO SUPPORT CONFIRMATION OF THE REPORTED ISSUE. NO PHOTO EVIDENCE WAS PROVIDED, SO THE ASSESSMENT WAS BASED ON DOCUMENTATION ONLY. BASED ON THE EXPANDED INVESTIGATION INCLUDING UPDATED EQMS SEARCHES AND THE DHR REVIEW NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH TRACKING AND TRENDING PER WI (MONTHLY TRIPS AND ALERTS) COMPLAINT UNCONFIRMED: FOLLOWING INVESTIGATION THE REPORTED FAILURE COULD NOT BE CONFIRMED FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT THE PATIENT FACED EVENTS WHERE THREE INFUSION SETS WERE LEAKING AT INSERTION SITE ON (B)(6)2024. THE INFUSION SETS HAD BEEN IN USE FOR LESS THAN ONE DAY. PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN SUCCESSFULLY NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777332 INSET II UNO INSET II 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002819 6002531 05705244018181

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female