BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET II

    MDR report key: 24108538 · Received January 19, 2026

    Report

    Report Number
    3003442380-2026-00006
    Event Type
    Malfunction
    Date Received
    January 19, 2026
    Date of Event
    December 28, 2025
    Report Date
    February 10, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016651
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR- (B)(4).- DEVICE 5 OF 6

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 (B)(4). MDR 3003442380-2026-00006. CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED COMMON DEVICE NAME UNDER D2, MODEL NUMBER, SERIAL NUMBER, PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) NUMBER, 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: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 10-FEB-2026 AGAINST "LOT NUMBER" "6012804" AND SIMILAR MALFUNCTION CODES: TUBING IS SPLIT (ALONG THE LENGTH OF THE TUBING) OR HAS PINHOLES, TUBING DAMAGE - SIGNIFICANT / EXTENSIVE, LEAK - TUBING DAMAGE SIGNIFICANT / EXTENSIVE THE REVIEW CONFIRMED THAT LOT 6012804 AND THE IDENTIFIED FAILURE MODE ARE NOT LINKED TO ANY SIMILAR NCRS OR CORRECTIVE AND PREVENTIVE ACTION (CAPA)S. NCR NON-CONFORMANCE (NC) 2190030 RELATES TO INCORRECT AUTOSOFT 90 LABELS FOUND IN BATCH 6012805, AND IT'S NOT RELATED TO THE REPORTED FAILURE MODE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 10-FEB-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL "6012804" AND SIMILAR MALFUNCTION CODES: TUBING IS SPLIT (ALONG THE LENGTH OF THE TUBING) OR HAS PINHOLES, TUBING DAMAGE - SIGNIFICANT / EXTENSIVE, LEAK - TUBING DAMAGE SIGNIFICANT / EXTENSIVE THE COUNT OF COMPLAINTS IS 1. THE COMPLAINT NUMBER IS (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6012804 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 122 AND MANUFACTURED IN THE LINE LASER INSET 6, ON 03-APR-2025 WITH A TOTAL OF (B)(4) UNITS. GLUE-TUBING LOT: THE LOT 5C05945 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 2 AND MANUFACTURED IN THE MACHINE ITL03 ON 02-APR-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5C05946 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 2 AND MANUFACTURED IN THE MACHINE ITL03 ON 03-APR-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5C03072 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 2 AND MANUFACTURED IN THE MACHINE ITL03 ON 19-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED IN ACCORDANCE WITH APPLICABLE PROCEDURES. ALL REQUIRED IN-PROCESS AND FINAL TESTS WERE COMPLETED AND MET SPECIFIED REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED THAT RELATE TO THE COMPLAINT CODE. CONCLUSION: DHR REVIEW SUPPORTS COMPLIANCE WITH MANUFACTURING AND QUALITY REQUIREMENTS; 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). COMPLAINT UNCONFIRMED: FOLLOWING INVESTIGATION THE REPORTED FAILURE COULD NOT BE CONFIRMED FOR THIS COMPLAINT. 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 CAPA DETERMINATION. NO NCRS OR CAPAS OF THE SAME OR SIMILAR NATURE WERE FOUND FOR LOT 6012804 AND RELATED MALFUNCTION CODES. 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

    REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT THE PATIENT FACED TUBING ISSUE WITH INFUSION SETS ON 28-DEC-2025. THE ISSUE OCCURRED WITH SIX INFUSION SETS ON (B)(6) 2025 AND (B)(6) 2025. THE PATIENT STATED TUBING WAS KINKED BY THE PIGTAIL FOR ALL EVENTS. 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
    169582 INSET II UNO INSET I 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001681 6012804 05705244016651

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female