BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET

    MDR report key: 23509612 · Received November 10, 2025

    Report

    Report Number
    3003442380-2025-16064
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    October 17, 2025
    Report Date
    November 5, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4), DEVICE 1 OF 2. E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: PATIENT COUNTRY: UNITED ARAB EMIRATES. 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)(6). THE BATCH 6001313, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 04-NOV-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL "6001313". THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001313 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 75 AND MANUFACTURED IN THE MACHINE 12 ON 15-MAY-2023, 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. TEST RESULTS: IN ORDER TO TEST THE PRODUCT, THE RETURNED SAMPLE FROM THE LOT HAVE BEEN REQUESTED. NO PHOTO OR PHYSICAL SAMPLE WAS PROVIDED. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION UNRELATED TO COMPLAINT CODE, ONE COMPLAINT TREND IDENTIFIED FOR THE LOT IN QUESTION, HOWEVER THE MALFUNCTION CODE BELONGS TO THE IC CRITICAL QUALITY LIST, AND THIS COMPLAINT REQUIRES FURTHER CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION ASSESSMENT.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED ARAB EMIRATES. THIS EMDR IS BEING SUBMITTED FOR UNKNOWN NUMBER OF QUANTITIES. IT WAS REPORTED BY THE PATIENT THAT THE BOX OF INFUSION SET MISSHAPED AND PACKAGING OF THE INFUSION SET WAS NOT SEALED PROPERLY OR NOT INTACTED PROPERLY (B)(6) 2025. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2582152 QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-399A 6001313 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown