BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMFORT

    MDR report key: 22768415 · Received August 11, 2025

    Report

    Report Number
    3003442380-2025-12648
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    July 22, 2025
    Report Date
    March 24, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244019553
    PMA / PMN Number
    K162812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED COMMON DEVICE NAME UNDER D2, MODEL NUMBER, SERIAL NUMBER, PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) NUMBER UNDER D4. 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 TUBING CONNECTOR DETACHED FROM INFUSION SET (CANNULA PART/BASE PIECE), TO LEAK BETWEEN TUBING AND SITE CONNECTOR DETACHMENT / SIGNIFICANT WETNESS, WHICH REQUIRES ADDITIONAL ACTIVITIES NOT INCLUDED IN THE ORIGINAL INVESTIGATION DATED 08/AUG/2025. COMPLAINT INVESTIGATION RESULTS - SUPPLEMENTAL INFORMATION: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 23-MAR-2026 AGAINST "LOT NUMBER" 6003925 AND SIMILAR MALFUNCTION CODES: LEAK BETWEEN TUBING AND SITE CONNECTOR DETACHMENT / SIGNIFICANT WETNESS, LEAKAGE FROM CONNECTION BETWEEN THE TUBING CONNECTOR AND THE INFUSION SET (CANNULA PART/BASE PIECE), TUBING DETACHED FROM TUBING-TUBING CONNECTOR, TUBING CONNECTOR IS CRACKED, SPLIT, DEFORMED, LEAKAGE MAY OCCUR. THE REVIEW CONFIRMED THAT LOT 6003925 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NONCONFORMING REPORTS (NCR)S OR CORRECTIVE AND PREVENTIVE ACTION (CAPA)S OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 23-MAR-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL 6003925 AND SIMILAR MALFUNCTION CODES: LEAK BETWEEN TUBING AND SITE CONNECTOR DETACHMENT / SIGNIFICANT WETNESS, LEAKAGE FROM CONNECTION BETWEEN THE TUBING CONNECTOR AND THE INFUSION SET (CANNULA PART/BASE PIECE), TUBING DETACHED FROM TUBING-TUBING CONNECTOR, TUBING CONNECTOR IS CRACKED, SPLIT, DEFORMED, LEAKAGE MAY OCCUR. THE COUNT OF COMPLAINTS IS 1. THE COMPLAINT NUMBERS IS (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003925 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 15 AND PACKAGING IN THE MACHINE 10, ON 25/OCT/2023, WITH A TOTAL OF (B)(4) UNITS. CANNULA PART: THE LOT 3K03142 WAS ASSEMBLED ACCORDING TO THE WI VERSION 12 ON-LINE INSPECTION FOR MACHINE LC04 ON 23-OCT-2024, WITH A TOTAL OF (B)(4) UNITS EACH. UNITS EACH. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WERE IDENTIFIED; NO MAINTENANCE EVENTS WERE RECORDED. TEST RESULTS: VISUAL TEST ACCORDING TO WI VERSION 3 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 1: STATIC PULL BASE-CONNECTOR ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, REFERENCE SAMPLES PASSED THE TEST. FUNCTIONAL TEST 2: CLICK ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, REFERENCE SAMPLES PASSED THE TEST. SEE ATTACHMENT DATABASE COMPLAINT (B)(4) COMPLAINT TEST REPORT FOR THE DETAILS. CAPA DETERMINATION ASSESSMENT - CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: BASED ON THE INVESTIGATION RESULTS, 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 DATED 08/AUG/2025 UNDER CHILD COMPLAINT INVESTIGATION RECORD (B)(4). THE INVESTIGATION HAS BEEN REVISED TO REFLECT THE UPDATED MALFUNCTION CODE REQUIREMENTS. THE ORIGINAL INVESTIGATION REMAINS VALID AND HAS NOT BEEN MODIFIED. AS PART OF THIS REASSESSMENT, AN UPDATED EQMS SEARCH WAS PERFORMED WHICH IDENTIFIED ONE RELATED COMPLAINT FOR LOT 6003925. 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 MALFUNCTION REMAINS UNCONFIRMED FOR THIS COMPLAINT.

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: CANADA.

    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 PATIENT'S INFUSION SET TUBING DETACHED FROM SITE ON (B)(6) 2025. THE INSERTION SITE WAS ABDOMEN. THE INFUSION SET WAS IN USE FOR ONE AND HALF DAY. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492642 COMFORT UNO COMFORT 60/17 SC1 MINI FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-378A 6003925 05705244019553

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown