BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET

    MDR report key: 23399539 · Received October 27, 2025

    Report

    Report Number
    3003442380-2025-15326
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    September 29, 2025
    Report Date
    October 31, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244017573
    PMA / PMN Number
    K160648
    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: ARGENTINA.

    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. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6011897 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011897 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND PACKAGING IN THE MULTIVAC M12 ON 02-MAR-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 WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. THE SUB-ASSEMBLY: ASSEMBLY OF THE LOT 5B03932 WAS MANUFACTURED ACCORDING TO THE WI VERSION 28 AND ASSEMBLED IN THE QUICKSET LINE, ON 02-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: ASSEMBLY OF THE LOT 5B03933 WAS MANUFACTURED ACCORDING TO THE WI VERSION 28 AND ASSEMBLED IN THE QUICKSET LINE, ON 02-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: ASSEMBLY OF THE LOT 5B02969 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 AND ASSEMBLED IN THE QUICKSET LINE, ON 21-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: ASSEMBLY OF THE LOT 5B03918 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 AND ASSEMBLED IN THE QUICKSET LINE, ON 26-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: ASSEMBLY OF THE LOT 5C00349 WAS MANUFACTURED ACCORDING TO THE WI VERSION 28 AND ASSEMBLED IN THE QUICKSET LINE, ON 03-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: ASSEMBLY OF THE LOT 5B04161 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 AND ASSEMBLED IN THE QUICKSET LINE, ON 21-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING OF THE LOT 5B04587 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE LINE MP04 AND MP08, ON 28-FEB-2025, WITH A TOTAL OF 120,000 UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING OF THE LOT 5B03916 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE LINE MP04 AND MP08, ON 26-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING OF THE LOT 5B03915 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE LINE MP04 AND MP08, ON 25-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING OF THE LOT 5B02965 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE LINE MP04 AND MP08, ON 19-FEB-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 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 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 ARGENTINA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET TUBING DETACHMENT EVENT ON (B)(6) 2025. THE SITE OF DETACHMENT WAS QUICK RELEASE. THE INSERTION SITE WAS ABDOMEN. THE INFUSION SET WAS IN USE FOR FEW HOURS. 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
    19409 QUICK SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL A/S MMT-397A 6011897 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown