BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET II

    MDR report key: 23756753 · Received December 9, 2025

    Report

    Report Number
    3003442380-2025-17312
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Date of Event
    November 4, 2025
    Report Date
    November 29, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR. 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 TO REVIEW THE DEVICE HISTORY RECORD (DHR) ASSOCIATED WITH THE REPORTED ISSUE. THE BATCH 6011918, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011918 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 76.0, IN THE LINE INSET 05, ON 12/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING THE LOT 5B00206 WAS MANUFACTURED ACCORDING TO THE WI VERSION 67.0 AND MANUFACTURED IN THE MACHINE SC02, ON 07/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5B00211 WAS MANUFACTURED ACCORDING TO THE WI VERSION 67.0 AND MANUFACTURED IN THE MACHINE SC02, ON 11/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5B00207 WAS MANUFACTURED ACCORDING TO THE WI VERSION 67.0 AND MANUFACTURED IN THE MACHINE SC02, ON 03/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5B00208 WAS MANUFACTURED ACCORDING TO THE WI VERSION 66.0 AND MANUFACTURED IN THE MACHINE SC02, ON 15/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.

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL - (B)(4) - MDR 3003442380-2025-17312- DEVICE 1 OF 1.

    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 NETHERLAND. IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET LEAKGE (B)(6) 2025 IN THE WHOLE BOX OF 10 INFUSION SETS. THE BLOACKAGE WAS IN THE TUBING. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2009009 INSET II UNO INSET II 80/6 GREY Y-CAP 10PAK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. UL3161 6011918

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown