BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMFORT

    MDR report key: 23320563 · Received October 17, 2025

    Report

    Report Number
    3003442380-2025-15107
    Event Type
    Malfunction
    Date Received
    October 17, 2025
    Date of Event
    September 23, 2025
    Report Date
    November 28, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018785
    PMA / PMN Number
    K162812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: A COMPLAINT INVESTIGATION HAS BEEN INITIATED TO REVIEW THE DEVICE HISTORY RECORD (DHR) ASSOCIATED WITH THE REPORTED ISSUE. THE BATCH 6012366 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6012366 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 21 AND PACKAGING IN THE MULTIVAC 14, ON 29/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, CANNULA THE LOT 5C01079 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 17 WELDING IN THE MACHINE LS04, ON 19/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, CANNULA THE LOT 5C03314 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 17 WELDING IN THE MACHINE LS04, ON 22/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING TUBING THE LOT 5C03312 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 67 IN THE GLUING OF CONNECTOR IN THE SC05 AND SC06, ON 28/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    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 UNITED STATES IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOCKAGE WAS IN THE TUBING. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2671308 COMFORT UNO COMFORT 60/17 TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002830 6012366 05705244018785

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female