BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-SET

    MDR report key: 22768405 · Received August 11, 2025

    Report

    Report Number
    3003442380-2025-12650
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    July 21, 2025
    Report Date
    October 13, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017818
    PMA / PMN Number
    K070430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    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 - 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 6010785, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010785 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND PACKAGING IN THE MACHINE MULTIVAC 12 ON 15-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, ASSEMBLY OF QUICK SET OF THE LOT 4M00092 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 AND MANUFACTURED IN THE LINE ASSEMBLY OF QUICK SET, ON 15-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, ASSEMBLY OF QUICK SET OF THE LOT 4M00093 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 AND MANUFACTURED IN THE LINE ASSEMBLY OF QUICK SET, ON 15-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING TUBE OF THE LOT 4M00059 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MACHINE 04-08 ON 07-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING TUBE OF THE LOT 4M01580 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MACHINE 04-08, ON 12-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING TUBE OF THE LOT 4L04252 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MACHINE 04-08, ON 25-NOV-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING TUBE OF THE LOT 4K06474 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MACHINE 04-08, ON 31-OCT-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING TUBE OF THE LOT 4K04377 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MACHINE 05, ON 19-OCT-2024, 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 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

    E1:PATIENT CITY: (B)(6). PATIENT COUNTRY: POLAND.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN POLAND. IT WAS REPORTED THAT PATIENT'S INFUSION SET TUBING DETACHED FROM CONNECTOR ON (B)(6) 2025. THE INSERTION SITE WAS ABDOMEN. THE INFUSION SET WAS IN USE FOR ONE DAY. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2159963 QUICK-SET UNO QUICK-SET 80/9 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-386A 6010785 05705244017818

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown