BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMFORT

    MDR report key: 24714047 · Received March 30, 2026

    Report

    Report Number
    3003442380-2026-99779
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 4, 2024
    Report Date
    February 25, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018693
    PMA / PMN Number
    K162812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 25-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. COMPLAINT INVESTIGATION RESULTS: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 24/MAR/2026 AGAINST LOT NUMBER 6002811 AND SIMILAR MALFUNCTION CODES: LEAK BETWEEN TUBING AND PUMP CONNECTOR/HUB - DETACHMENT /SIGNIFICANT WETNESS, TUBING DETACHED FROM HUBLEAKAGE FROM TUBING OR THE INTERFACE BETWEEN THE TUBING AND THE CONNECTORS (REFERS TO CONNECTORS IN BOTH ENDS OF THE TUBING). THE REVIEW CONFIRMED THAT LOT 6002811 WAS ASSOCIATED WITH NON-CONFORMANCE (NC) 1768686 FOR A SHIPMENT HOLD WAS IMPLEMENTED DUE TO AN OUT OF SPECIFICATION AIR VIABLE TEST. HOWEVER, THIS NONCONFORMANCE IS NOT RELATED TO THE REPORTED FAILURE MODE AND IS NOT ASSOCIATED WITH ANY NCS OR CAPAS OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 24/MAR/2026 AGAINST LOT NUMBER CRITERIA EQUAL 6002811 AND SIMILAR MALFUNCTION CODES: LEAK BETWEEN TUBING AND PUMP CONNECTOR/HUB - DETACHMENT /SIGNIFICANT WETNESS, TUBING DETACHED FROM HUB LEAKAGE FROM TUBING OR THE INTERFACE BETWEEN THE TUBING AND THE CONNECTORS (REFERS TO CONNECTORS IN BOTH ENDS OF THE TUBING). THE NUMBER OF COMPLAINTS IS 1. THE COMPLAINT NUMBERS ARE (B)(4). DHR REVIEW: THE LOT 6002811 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION (WI) VERSION 15 AND MANUFACTURED IN THE M10, ON 26/AUG/2023 WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: CANNULA: LOT 3H01830 WAS MANUFACTURED ACCORDING TO THE WI-4905277 VERSION 11 AND MANUFACTURED IN THE MACHINE LC05, ON 23-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3H03933 WAS MANUFACTURED ACCORDING TO THE WI-4905277 VERSION 11 AND MANUFACTURED IN THE MACHINE LC05, ON 27-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3F03253 WAS MANUFACTURED ACCORDING TO THE WI-4905277 VERSION 11 AND MANUFACTURED IN THE MACHINE LC05, ON 17-JUN-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: TUBING GLUING LOT 3H01843 WAS MANUFACTURED ACCORDING TO THE WI-4905294 VERSION 55 AND MANUFACTURED IN THE MACHINE SC08, ON 23-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3H01842 WAS MANUFACTURED ACCORDING TO THE WI-4905294 VERSION 55 AND MANUFACTURED IN THE MACHINE SC07, ON 21-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT AN CAPA 1694785 WAS FOUND FOR MISMATCH BETWEEN ENGINEERING AND PRODUCTION BOM IN THE LOT NUMBER 6002811 AND THEREFORE THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE 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: THE INVESTIGATION FOR THIS COMPLAINT WAS PREVIOUSLY COMPLETED ON 13-MAR 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 ONE RELATED COMPLAINTS FOR LOT 6002811. NO NON-CONFORMANCE REPORT (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.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFUSION SET TUBING DETACHMENT FROM THE HUB ON (B)(6) 2024, AFTER TWO HOURS OF USE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779836 COMFORT UNO COMFORT SHORT 60/13 TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002827 6002811 05705244018693

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female