BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET

    MDR report key: 23251938 · Received October 9, 2025

    Report

    Report Number
    3003442380-2025-14645
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    September 11, 2025
    Report Date
    November 1, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K160648
    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

    E1: PATENT'S CITY: (B)(6). PATIENT'S COUNTRY: (B)(6), U.S.

    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 UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6011992 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011992 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURING IN THE MACHINE 12 ON 09-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY OF THE LOT 5C00035 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 29 ON 09-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY OF THE LOT 5C00036 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 29 ON 09-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY OF THE LOT 5C00037 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 29 ON 09-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

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6), UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED AN EVENT WHERE CANNULA WAS NOT BEEN INSERTED ON (B)(6) 2025 LEADING TO LEAKAGE. THE INFUSION SET WAS USED FOR ONE DAY. THE QUICK RELEASE WAS TIGHTLY CONNECTED. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2663303 QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-399A 6011992

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown