BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET II

    MDR report key: 23495317 · Received November 7, 2025

    Report

    Report Number
    3003442380-2025-15893
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    October 13, 2025
    Report Date
    December 23, 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 3003442380-2025-15893. 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: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 22-DEC-2025 AGAINST "LOT NUMBER 6010092 AND SIMILAR MALFUNCTION CODE(S): DAMAGED SOFT CANNULA. (E.G., PENETRATED BY INTRODUCER NEEDLE) COMPONENT DEFECT- MALFUNCTION CODE NOT ON LIST. THE REVIEW CONFIRMED THAT LOT 6010092 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NCRS OR CAPAS OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 22-DEC-2025 AGAINST "LOT NUMBER" CRITERIA EQUAL 6010092 AND SIMILAR MALFUNCTION CODES DAMAGED SOFT CANNULA. (E.G., PENETRATED BY INTRODUCER NEEDLE) COMPONENT DEFECT- MALFUNCTION CODE NOT ON LIST. THE COUNT OF COMPLAINT IS 1. THE COMPLAINT NUMBER IS (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010092 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 74 AND MANUFACTURED IN THE LINE 06 ON 06/NOV/2024 WITH A TOTAL OF (B)(4) UNITS. NON-CONFORMANCE NC 2081027 RELATED TO LOW TEMPERATURE IN HEATING AERATION PHASE AT STERIGENICS G.P DURING STERILIZATION PROCESS AND IS NOT ASSOCIATED TO REPORTED ISSUE ON THIS COMPLAINT. NON-CONFORMANCE NC 2090604 RELATED TO MISMATCH BETWEEN CUSTOMER NAME INDICATED ON DOCUMENT (B)(4) CUSTOMER ADDRESS LIST AND SAP PROCESS AND IS NOT ASSOCIATED TO REPORTED ISSUE ON THIS COMPLAINT. THEREFORE, THE OVERALL REVIEW OF THE DHR CONFIRMS THAT ALL REQUIRED PROCESS-RELATED TESTS WERE COMPLETED AND MET THE APPLICABLE REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED IN RELATION TO THE COMPLAINT CODE. CONCLUSION: DHR REVIEW IDENTIFIED MINOR FINDINGS. THEY WERE MANAGED ACCORDING TO PROCEDURE AND DID NOT IMPACT COMPLIANCE; NO ISSUES NOTED. VISUAL EVIDENCE REVIEW:NO PHOTO WAS PROVIDED TO SUPPORT VISUAL CONFIRMATION OF THE REPORTED ISSUE. CONCLUSION: UNABLE TO PERFORM VISUAL VERIFICATION; ASSESSMENT BASED ON AVAILABLE DOCUMENTATION ONLY. CAPA DETERMINATION ASSESSMENT - CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: BASED ON THE INVESTIGATION, NO FURTHER INVESTIGATION IS REQUIRED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH TRACKING AND TRENDING PER WI (MONTHLY TRIPS AND ALERTS). CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: A COMPREHENSIVE REVIEW WAS CONDUCTED, INCLUDING EQMS QUERIES, SIMILAR COMPLAINT SEARCHES, DEVICE HISTORY RECORD REVIEW, VISUAL EVIDENCE ASSESSMENT, AND CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION. NO NCRS OR CAPAS OF THE SAME OR SIMILAR NATURE WERE FOUND FOR LOT 6010092 AND RELATED MALFUNCTION CODES FOR CANNULA DAMAGED. ONE COMPLAINT WAS IDENTIFIED FOR THIS LOT, BUT NO TREND OR SYSTEMIC ISSUE WAS DETECTED. THE MANUFACTURING RECORDS CONFIRMED THAT THE LOT WAS PRODUCED IN COMPLIANCE WITH ALL REQUIREMENTS, WITH NO DEVIATIONS OR MAINTENANCE EVENTS NOTED. NO PHOTO EVIDENCE WAS PROVIDED, SO THE ASSESSMENT WAS BASED ON DOCUMENTATION ONLY. BASED ON THESE RESULTS, NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED, AND NO FURTHER INVESTIGATION IS REQUIRED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH ROUTINE TRACKING AND TRENDING.

    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 AUSTRIA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET DAMAGED SOFT CANNULA EVENT ON (B)(6) 2025. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181708 INSET II UNO INSET II 46/6 GREY Y-CAP 10PAK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 86-046-52B6 6010092

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown