BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET

    MDR report key: 23242483 · Received October 8, 2025

    Report

    Report Number
    8021545-2025-02656
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    September 10, 2025
    Report Date
    October 23, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    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: COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6011715, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011715 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 120 IN THE LINE 06, ON 15/FEB/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING OF THE LOT 5B01679 WAS MANUFACTURED ACCORDING TO THE WI VERSION 66 AND MANUFACTURED IN THE MACHINE SC09, ON 11-FEB-2025, WITH A TOTAL OF (B)(4)UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING OF THE LOT 5A06566 WAS MANUFACTURED ACCORDING TO THE WI VERSION 66 AND MANUFACTURED IN THE MACHINE SC04, ON 30-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 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 THE UNITED STATES. ON (B)(6) 2025, THE PATIENT REPORTEDLY EXPERIENCED AN INCIDENT WHERE THE INFUSION SET CANNULA TUBING BECAME KINKED WITHIN THE NOTCH. THIS EVENT OCCURRED THREE OR MORE HOURS AFTER INSERTION OF THE INFUSION SET. NO FURTHER INFORMATION WAS 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
    2481389 INSET AUTOSOFT XC, 10 PACK, 6MM/23', BLUE, INFUSION SET FPA UNOMEDICAL A/S 1001683 6011715

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male