BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-SET

    MDR report key: 22846932 · Received August 20, 2025

    Report

    Report Number
    3003442380-2025-13035
    Event Type
    Malfunction
    Date Received
    August 20, 2025
    Date of Event
    July 23, 2025
    Report Date
    July 24, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K070430
    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: COLOMBIA. THE INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED. THE BATCH 6011473 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2 FOR THE CODE TUBING CONNECTOR DETACHED FROM INFUSION SET (CANNULA PART/BASE PIECE) COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. TEST RESULTS: VISUAL TEST ACCORDING TO WI VERSION 3 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST AIR FLOW ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011473 WAS MANUFACTURED ACCORDING TO THE WI VERSION 82 MANUFACTURED IN THE MULTIVAC 12, ON 03/FEB/2025, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY: THE LOT 5A05095 WAS ASSEMBLED ACCORDING TO WI VERSION 27 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 02 FEB 2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5A05096 WAS ASSEMBLED ACCORDING TO WI VERSION 27 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 02 FEB 2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5A02504 WAS ASSEMBLED ACCORDING TO WI VERSION 27 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 19 JAN 2025, WITH A TOTAL OF (B)(4) UNITS GLUING TUBING: THE LOT 5A05975 WAS ASSEMBLED ACCORDING TO WI VERSION 42 ON-LINE INSPECTION FOR AUTOMATIC GLUING OF QUICK SET. MACHINE 04, 08 ON 31 JAN 2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5A06190 WAS ASSEMBLED ACCORDING TO WI VERSION 42 ON-LINE INSPECTION FOR AUTOMATIC GLUING OF QUICK SET, MACHINE 04, 08 ON 01 FEB 2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5A00998 WAS ASSEMBLED ACCORDING TO WI VERSION 42 ON-LINE INSPECTION FOR AUTOMATIC GLUING OF QUICK SET, MACHINE 04, 08 ON 18 JAN 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 WERE IDENTIFIED; NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 11/AUG/2025 AGAINST MALFUNCTION CODE TUBING CONNECTOR DETACHED AND LOT 6011473 AND NO OTHER COMPLAINTS HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, 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 COLOMBIA. IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET TUBING DETACHMENT EVENT ON (B)(6) 2025. THE TUBING WAS DETACHED FROM THE SITE. THE INSERTION SITE WAS THE LEG. INFUSION SET WAS USED FOR THREE DAYS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1468449 QUICK-SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-399A 6011473 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown