BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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    MDR report key: 24713599 · Received March 30, 2026

    Report

    Report Number
    3003442380-2026-99819
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    February 25, 2024
    Report Date
    February 25, 2026
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244019317
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: (B)(6). PATIENT COUNTRY: UNITED STATES. 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. BASED ON THE REVIEW COMPLETED ON 25-FEB-2026 AND INVESTIGATION COMPLETED ON 20-MAR-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. COMPLAINT INVESTIGATION RESULTS: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 19/MAR/2026 AGAINST LOT NUMBER 6001818 AND SIMILAR MALFUNCTION CODES: LEAK BETWEEN TUBING AND SITE CONNECTOR DETACHMENT / SIGNIFICANT WETNESS, LEAKAGE FROM CONNECTION BETWEEN THE TUBING CONNECTOR AND THE INFUSION SET (CANNULA PART/BASE PIECE), TUBING DETACHED FROM TUBING-TUBING CONNECTOR, TUBING CONNECTOR IS CRACKED, SPLIT, DEFORMED, LEAKAGE MAY OCCUR. THE REVIEW CONFIRMED THAT LOT 6001818 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NON CONFORMANCE REPORT (NCRS) OR CAPAS OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 19/MAR/2026 AGAINST LOT NUMBER CRITERIA EQUAL 6001818 AND SIMILAR MALFUNCTION CODES: LEAK BETWEEN TUBING AND SITE CONNECTOR - DETACHMENT / SIGNIFICANT WETNESS, LEAKAGE FROM CONNECTION BETWEEN THE TUBING CONNECTOR AND THE INFUSION SET (CANNULA PART/BASE PIECE), TUBING DETACHED FROM TUBING-TUBING CONNECTOR, TUBING CONNECTOR IS CRACKED, SPLIT, DEFORMED, LEAKAGE MAY OCCUR. THE NUMBER OF COMPLAINTS IS 2. THE COMPLAINTS NUMBERS ARE COMPLAINT (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001818 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION (WI) VERSION 92 AND MANUFACTURED IN MACHINE/LINE: M10, ON 11-JUN-2023 WITH A TOTAL OF (B)(4) UNITS. SUB-ASSEMBLY. TUBE: THE LOT 3F01743 WAS MANUFACTURED ACCORDING TO WI VERSION 55 AND MANUFACTURED IN MACHINE/LINE: SC05, ON 11-JUN-2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F01744 WAS MANUFACTURED ACCORDING TO WI VERSION 55 AND MANUFACTURED IN MACHINE/LINE: SC06, ON 11-JUN-2023 WITH A TOTAL OF (B)(4) UNITS. SUB-ASSEMBLY. CANNULA: THE LOT 3F01798 WAS MANUFACTURED ACCORDING TO WI VERSION 31 AND MANUFACTURED IN MACHINE/LINE: LS24, ON 11-JUN-2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F01789 WAS MANUFACTURED ACCORDING TO WI VERSION 31 AND MANUFACTURED IN MACHINE/LINE: LS24, ON 11-JUN-2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F01791 WAS MANUFACTURED ACCORDING TO WI VERSION 31 AND MANUFACTURED IN MACHINE/LINE: LS11, ON 11-JUN-2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F01790 WAS MANUFACTURED ACCORDING TO WI VERSION 31 AND MANUFACTURED IN MACHINE/LINE: LS25, ON 11-JUN-2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F01799 WAS MANUFACTURED ACCORDING TO WI VERSION 31 AND MANUFACTURED IN MACHINE/LINE: LS25, ON 11-JUN-2023 WITH A TOTAL OF (B)(4) UNITS. SUB-ASSEMBLY. CONNECTOR: THE LOT 3F01512 WAS MANUFACTURED ACCORDING TO WI VERSION 35 AND MANUFACTURED IN MACHINE/LINE: PEGADO 3, ON 11-JUN-2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F01514 WAS MANUFACTURED ACCORDING TO WI VERSION 35 AND MANUFACTURED IN MACHINE/LINE: PEGADO 3, ON 11-JUN-2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F00574 WAS MANUFACTURED ACCORDING TO WI VERSION 35 AND MANUFACTURED IN MACHINE/LINE: PEGADO 3, ON 09-JUN-2023 WITH A TOTAL OF (B)(4) UNITS. 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: THE INVESTIGATION FOR THIS COMPLAINT WAS COMPLETED ON 08-APR-2024 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 TWO RELATED COMPLAINTS FOR LOT 6001818. NO NON CONFORMANCE REPORT (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 WI (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 EXPERIENCED INFUSION SET TUBING DETACHMENT AT THE SITE CONNECTOR ON (B)(6) 2024. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779509 CONTACT DETACH UNO CONTACT DETACH G29 60/6 SC1 MIMX FPA UNOMEDICAL UM-D MMT-864A 6001818 05705244019317

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown