BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMFORT

    MDR report key: 23787892 · Received December 12, 2025

    Report

    Report Number
    3003442380-2025-17365
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    November 11, 2025
    Report Date
    December 1, 2025
    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

    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 6012368, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DHR REVIEW: THE LOT 6012368 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 21.0, IN THE MULTIVAC M14, ON 24/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: CANNULA THE LOT 5C00538 WAS MANUFACTURED ACCORDING TO THE WI VERSION 17.0 AND MANUFACTURED IN THE MACHINE LC05, ON 09/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5C01081 WAS MANUFACTURED ACCORDING TO THE WI VERSION 17.0 AND MANUFACTURED IN THE MACHINE LC05, ON 11/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5C01092 WAS MANUFACTURED ACCORDING TO THE WI VERSION 17.0 AND MANUFACTURED IN THE MACHINE LC05, ON 16/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING THE LOT 5C03313 WAS MANUFACTURED ACCORDING TO THE WI VERSION 17.0 AND MANUFACTURED IN THE MACHINE LC01, ON 22/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE 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 THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET TUBING DETACHMENT ON (B)(6) 2025. THE SITE OF DETACHMENT WAS P-CAP. THE INSERTION SITE WAS RIGHT LEG. THE INFUSION SET WAS IN USE FOR 2 DAYS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2713282 COMFORT UNO COMFORT SHORT 60/13 SC1 MIN FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-381A 6012368 05705244019584

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown