BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-SET

    MDR report key: 22836801 · Received August 19, 2025

    Report

    Report Number
    3003442380-2025-12938
    Event Type
    Malfunction
    Date Received
    August 19, 2025
    Date of Event
    July 23, 2025
    Report Date
    August 7, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K991759
    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: CANADA. 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: THE REFERENCE SAMPLES FOR THE LOT 6011367 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE COMPLAINT (B)(4) ON 08-JUL- 2025. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR STATIC PULL TUBING-TUBING CONNECTOR. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011367 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND PACKAGING IN THE MACHINE 12, ON 31/JAN/2025, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY: THE LOT 5A04106 WAS ASSEMBLED ACCORDING TO THE WI VERSION 27 ON-LINE INSPECTION ON 21-OCT-2024, WITH A TOTAL OF (B)(4) UNITS EACH. GLUING CONNECTOR: THE LOT 5A03846 WAS GLUED ACCORDING TO THE WI VERSION 42, MACHINE 04 AND 08 ON 29-JAN-2025, WITH A TOTAL OF (B)(4) UNITS EACH. THE LOT 4M01580 WAS GLUED ACCORDING TO THE WI VERSION 42, MACHINE 04 AND 08 ON 12-DEC-2024, WITH A TOTAL OF (B)(4) UNITS EACH. 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/JUL/2025 AGAINST MALFUNCTION CODE TUBING DETACHED FROM TUBING-TUBING CONNECTOR AND LOT 6011367 AND ONE MORE COMPLAINT HAS BEEN REGISTERED IN DATA FOR THE SAME LOT AND MALFUNCTION CODE. A SECOND QUERY WAS RUN IN DATABASE ON 07/AGO/2025 AGAINST MALFUNCTION CODE TUBING DETACHED FROM TUBING-TUBING CONNECTOR AND LOT 6011367 AND ONE MORE COMPLAINT 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.

    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. THE REFERENCE SAMPLES FOR THE LOT 6011367 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE COMPLAINT (B)(4) ON 08-JUL- 2025. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR STATIC PULL TUBING-TUBING CONNECTOR. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011367 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND PACKAGING IN THE MACHINE 12, ON 31/JAN/2025, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY: THE LOT 5A04106 WAS ASSEMBLED ACCORDING TO THE WI VERSION 27 ON-LINE INSPECTION ON 21-OCT-2024, WITH A TOTAL OF (B)(4) UNITS EACH. GLUING CONNECTOR: THE LOT 5A03846 WAS GLUED ACCORDING TO THE WI VERSION 42, MACHINE 04 AND 08 ON 29-JAN-2025, WITH A TOTAL OF (B)(4) UNITS EACH. THE LOT 4M01580 WAS GLUED ACCORDING TO THE WI VERSION 42, MACHINE 04 AND 08 ON 12-DEC-2024, WITH A TOTAL OF (B)(4) UNITS EACH. 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/JUL/2025 AGAINST MALFUNCTION CODE TUBING DETACHED FROM TUBING-TUBING CONNECTOR AND LOT 6011367 AND ONE MORE COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. A SECOND QUERY WAS RUN IN DATABASE ON 07/AGO/2025 AGAINST MALFUNCTION CODE TUBING DETACHED FROM TUBING-TUBING CONNECTOR AND LOT 6011367 AND ONE MORE COMPLAINT 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 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 CANADA. IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET TUBING DETACHEMENT EVENT ON (B)(6) 2025. THE TUBING WAS DETACHED FROM QUICK RELEASE. INFUSION SETS WERE USED FOR ONE DAY. THE INSERTION SITE WAS THE ABDOMEN. 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
    2205088 QUICK-SET UNO QUICK-SET 80/6 SC1 MCAN FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-387A600 6011367

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown