BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-SET

    MDR report key: 22712793 · Received August 5, 2025

    Report

    Report Number
    3003442380-2025-12266
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Date of Event
    July 16, 2025
    Report Date
    October 16, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017931
    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:THE UNITED ARAB EMIRATES.

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4. 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 - REVISION (B)(4) OF (B)(4) DOES NOT REQUIRE A COMPLAINT THAT IS TYPE 2 REPORTABLE TO OPEN A CHILD INVESTIGATION. THIS CHILD INVESTIGATION WAS OPENED AGAINST A PREVIOUS REVISION OF (B)(4). COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6001151, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DHR REVIEW: THE LOT 6001151 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 75 AND MANUFACTURED IN THE MACHINE MULTIVAC 12 ON 26/APR/2023, WITH A TOTAL OF (B)(4) UNITS. GLUE-TUBING LOT: THE LOT 3D01868 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 AND MANUFACTURED IN THE MACHINE MP08 ON 21/APR/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3D01869 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 AND MANUFACTURED IN THE MACHINE MP04 ON 24/APR/2023, 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: ONE EXTENDED WAS RAISED DURING THE PROCESS UNRELATED TO THE MALFUNCTION REPORTED, THEREFORE, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT 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 THE UNITED ARAB EMIRATES IT WAS REPORTED THAT THE QUICK RELEASE OF THE INFUSION SET WAS BROKEN LEADING TO LEAKAGE FROM THE QUICK RELEASE ON (B)(6) 2025. THE INFUSION SET WAS IN USE FOR ONE DAY. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. 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
    28620 QUICK-SET UNO QUICK-SET 110/6 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-398A 6001151 05705244017931

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown