BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMFORT

    MDR report key: 24701499 · Received March 26, 2026

    Report

    Report Number
    3003442380-2026-99965
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    January 31, 2024
    Report Date
    February 25, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244019584
    PMA / PMN Number
    K162812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6) PATIENT COUNTRY: CZECH REPUBLIC. 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 12-FEB-2026 THIS MEDICAL DEVICE RECORD (MDR) IS BEING SUBMITTED AS THE INITIAL REPORT. ADDITIONAL INFORMATION - THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS H11: INVESTIGATION SUMMARY. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND LEAK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE BATCH RECORD 6002483 WAS VERIFIED AND IT WAS FOUND WITHIN SPECIFICATIONS. COMPLAINT INVESTIGATION RESULTS ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 12/MAR/2026 AGAINST LOT NUMBER 6002611 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 6002611 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NON CONFORMANCE REPORTS (NCR) OR CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 12/MAR/2026 AGAINST LOT NUMBER CRITERIA EQUAL 6002611 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 1. THE COMPLAINT NUMBERS ARE COMPLAINT (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6002611 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION (WI) AND MANUFACTURED IN THE M10 LINE ON 13/AUG/2023 WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: CANNULA LOT 3G01408 WAS MANUFACTURED ACCORDING TO THE WI AND ASSEMBLED IN THE CANNULA COMFORT LC05 LINE, ON 13-JUL-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3G05463 WAS MANUFACTURED ACCORDING TO THE WI AND ASSEMBLED IN THE LC05 LINE, ON 08-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3G01407 WAS MANUFACTURED ACCORDING TO THE WI AND ASSEMBLED IN THE CANNULA COMFORT LC05 LINE, ON 11-JUL-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3G05461 WAS MANUFACTURED ACCORDING TO THE WI AND ASSEMBLED IN THE CANNULA COMFORT LC04 LINE, ON 05-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3G05462 WAS MANUFACTURED ACCORDING TO THE WI AND ASSEMBLED IN THE CANNULA COMFORT LC05 LINE, ON 06-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3G01098 WAS MANUFACTURED ACCORDING TO THE WI AND ASSEMBLED IN THE CANNULA COMFORT LC05 LINE, ON 11-JUL-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3H03155 WAS MANUFACTURED ACCORDING TO THE WI AND ASSEMBLED IN THE CANNULA COMFORT LC05 LINE, ON 23-AUG-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. 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). THE INVESTIGATION FOR THIS COMPLAINT WAS PREVIOUSLY COMPLETED ON 06-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 ONE RELATED COMPLAINT FOR LOT 6002611. 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)

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4) EVENT OCCURED IN CZECH REPUBLIC IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAKAGE AT THE INFUSION SITE ON (B)(6) 2024. THE INSERTION SITE WAS THE ABDOMEN. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767075 COMFORT UNO COMFORT SHORT 60/13 SC1 MIN FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-381A 6002611 05705244019584

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown