BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET 30

    MDR report key: 24711260 · Received March 30, 2026

    Report

    Report Number
    3003442380-2026-99700
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    October 8, 2023
    Report Date
    February 25, 2026
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244018365
    PMA / PMN Number
    K061374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNOMEDICAL HEREBY SUBMITS THIS INITIAL REPORT AS PART OF ITS COMPLAINT REMEDIATION ACTIVITIES CONDUCTED UNDER A CORRECTIVE AND PREVENTIVE ACTION (CAPA)/FDA ACTION PLAN. THIS SUBMISSION INCLUDES A RETROSPECTIVE REASSESSMENT OF PREVIOUSLY EVALUATED COMPLAINTS. UNOMEDICAL IS PROVIDING THIS INITIAL INFORMATION IN ACCORDANCE WITH THE REPORTING REQUIREMENTS SET FORTH IN 21 CFR PART 803. ANY FIELDS LEFT BLANK INDICATE THAT THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR REMAINS UNCHANGED. BASED ON THE REVIEW COMPLETED ON 25-FEB-2026 AND INVESTIGATION COMPLETED ON 18-MARCH-2026 THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED AS THE INITIAL REPORT. 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. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND LEAK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE BATCH RECORD 6000149 WAS VERIFIED AND IT WAS FOUND WITHIN SPECIFICATIONS. COMPLAINT INVESTIGATION RESULTS: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 18/MAR/2026 AGAINST LOT NUMBER 6000149 AND SIMILAR MALFUNCTION CODES: LEAKAGE FROM INFUSION SITE (CANNULA BASE PART/CANNULA) (SPECIFIC CAUSE NOT IDENTIFIED), INSERTION SITE EGRESS - TRACE MOISTURE / SUPERFICIAL WETNESS. THE REVIEW CONFIRMED THAT LOT 6000149 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NON CONFORMANCE REPORT (NCRS) OR CORRECTIVE AND PREVENTIVE ACTION (CAPA) OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 18/MAR/2026 AGAINST LOT NUMBER CRITERIA EQUAL 6000149 AND SIMILAR MALFUNCTION CODES:LEAKAGE FROM INFUSION SITE (CANNULA BASE PART/CANNULA) (SPECIFIC CAUSE NOT IDENTIFIED), INSERTION SITE EGRESS - TRACE MOISTURE / SUPERFICIAL WETNESS. THE NUMBER OF COMPLAINTS IS 1. THE COMPLAINT NUMBERS ARE COMPLAINT (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6000149 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION (WI) VERSION 21 AND MANUFACTURED IN THE LINE 1, ON 12/MAR/2023 WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT DURING THE OUTGOING TEST 4 AN EXTENDED WAS FOUND FOR SHIFTED TYVEK IN TWO SAMPLE IN LOT 600149 AND THEREFORE 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: 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 WORK INSTRUCTION (WI) (MONTHLY TRIPS AND ALERTS). THE INVESTIGATION FOR THIS COMPLAINT WAS PREVIOUSLY COMPLETED ON 25-OCT 2023 UNDER CHILD COMPLAINT INVESTIGATION RECORD (B)(4). THE INVESTIGATION HAS BEEN REVISED TO REFLECT THE UPDATED MALFUNCTION CODE AND NEW REPORTABILITY REQUIREMENTS. THE ORIGINAL INVESTIGATION REMAINS VALID AND HAS NOT BEEN MODIFIED. AS PART OF THIS REASSESSMENT, AN UPDATED EQMS SEARCH WAS PERFORMED WHICH IDENTIFIED ONE RELATED COMPLAINTS FOR LOT 6000149. NO NCRS, CAPAS, TRENDS, OR SYSTEMIC ISSUES WERE FOUND. AS REQUIRED UNDER THE UPDATED REPORTABILITY CRITERIA, A FULL DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED. ALL IN PROCESS AND FINAL INSPECTIONS MET SPECIFICATION REQUIREMENTS, AND NO DEVIATIONS, REWORK ACTIVITIES, OR MAINTENANCE EVENTS ASSOCIATED WITH THE MALFUNCTION WERE IDENTIFIED. NO VISUAL EVIDENCE WAS AVAILABLE TO SUPPORT CONFIRMATION OF THE REPORTED ISSUE. NO PHOTO EVIDENCE WAS PROVIDED, SO THE ASSESSMENT WAS BASED ON DOCUMENTATION ONLY. BASED ON THE EXPANDED INVESTIGATION INCLUDING UPDATED EQMS SEARCHES AND THE DHR REVIEW NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH TRACKING AND TRENDING PER WORK INSTRUCTION (WI) (MONTHLY TRIPS AND ALERTS). COMPLAINT UNCONFIRMED: FOLLOWING INVESTIGATION THE REPORTED FAILURE COULD NOT BE CONFIRMED FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE EVENT AT THE SITE ON (B)(6) 2023 AND THE INFUSION SET HAS BEEN IN USE FOR ONE DAY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775434 INSET 30 UNO INSET 30 60/13 GREY TCAP 10PK INT FPA UNOMEDICAL UM-D 1002825 6000149 05705244018365

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female