BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET

    MDR report key: 24712412 · Received March 30, 2026

    Report

    Report Number
    3003442380-2026-99763
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    October 30, 2023
    Report Date
    February 25, 2026
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244016927
    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 1 OF 4 UNOMEDICAL HEREBY SUBMITS THIS INITIAL REPORT AS PART OF ITS COMPLAINT REMEDIATION ACTIVITIES CONDUCTED UNDER A 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 11-MAR-2026 THIS MDR IS BEING SUBMITTED AS THE INITIAL REPORT. ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. INVESTIGATION SUMMARY: THIS INVESTIGATION HAS BEEN UPDATED BECAUSE THE MALFUNCTION CODE CHANGED FROMTUBING, CONNECTOR DETACHED FROM INFUSION SET (CANNULA PART/BASE PIECE). TOLEAK BETWEEN TUBING AND SITE CONNECTOR - DETACHMENT / SIGNIFICANT WETNESS., WHICH REQUIRES ADDITIONAL ACTIVITIES NOT INCLUDED IN THE ORIGINAL INVESTIGATION DATED 30-NOV-2023. THE ORIGINAL INVESTIGATION REMAINS VALID AND HAS NOT BEEN MODIFIED. AS PART OF THIS REASSESSMENT, THE FOLLOWING ELEMENTS WERE ADDED TO ALIGN WITH CURRENT. INVESTIGATION REQUIREMENTS: COMPLAINT INVESTIGATION RESULTS: ELECTRONIC QUALITY MANAGEMENT SYSTEM SEARCH: A QUERY WAS RUN IN THE EQMS ON 10/MAR/2026 AGAINST LOT NUMBER 6000705 AND SIMILAR MALFUNCTION CODES: TUBING CONNECTOR DETACHED FROM INFUSION SET (CANNULA PART/BASE PIECE) , LEAK BETWEEN TUBING AND SITE CONNECTOR - DETACHMENT / SIGNIFICANT WETNESS. THE REVIEW CONFIRMED THAT LOT 6000705 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NON CONFORMANCE REPORT OR CORRECTIVE AND PREVENTIVE ACTION OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 10/MAR/2026 AGAINST LOT NUMBER CRITERIA EQUAL 6000705 AND SIMILAR MALFUNCTION CODES: TUBING CONNECTOR DETACHED FROM INFUSION SET (CANNULA PART/BASE PIECE) , LEAK BETWEEN TUBING AND SITE CONNECTOR - DETACHMENT / SIGNIFICANT WETNESS. THE NUMBER OF COMPLAINTS IS 1. THE COMPLAINT NUMBERS IS COMPLAINT (B)(4). DEVICE HISTORY RECORD REVIEW: THE LOT 6000705 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION VERSION 65 AND MANUFACTURED IN THE INSET 06 LINE ON 03/MAY/2023 WITH A TOTAL OF (B)(4). REVIEW OF THE DHR SHOWED THAT DURING THE OUTGOING TEST AN (B)(4) WAS FOUND FOR STERILIZATION SOFTWARE UPGRADED IN THE LOT NUMBER 6000705 AND THEREFORE THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED THAT RELATE TO THE COMPLAINT CODE. THE SUB-ASSEMBLY: GLUING TUBING LOT 3D03085 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION VERSION 55 AND ASSEMBLED IN THE SC02 LINE ON 02-MAY-2023, WITH A TOTAL OF (B)(4). 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 (MONTHLY TRIPS AND ALERTS). COMPLAINT INVESTIGATION RESULTS: THE INVESTIGATION FOR THIS COMPLAINT WAS PREVIOUSLY COMPLETED ON 30-NOV-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 COMPLAINT FOR LOT 6000705. 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 (MONTHLY TRIPS AND ALERTS) COMPLAINT UNCONFIRMED: FOLLOWING INVESTIGATION, THE MALFUNCTION REMAINS UNCONFIRMED FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED INFUSIONSET TUBING DETACHED FROM CONNECTOR EVENT ON 30-OCT-2023. THE INFUSION SET WAS USED FOR ONE TO TWO DAYS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777922 INSET UNO INSET I 110/6 GREY TCAP 10PK INT FPA UNOMEDICAL UM-D 1001728 6000705 05705244016927

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female