BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 21802780 · Received April 8, 2025

    Report

    Report Number
    3003442380-2025-05731
    Event Type
    Malfunction
    Date Received
    April 8, 2025
    Date of Event
    March 6, 2025
    Report Date
    June 27, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 FOR THE LOT 6007983 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE COMPLAINT (B)(4) ON 04/JUN/2025. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND LEAK TEST. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE COMPLAINT (B)(4) TEST REPORT.PDF ATTACHED IN THIS RECORD. DEVICE HISTORY RECORD (DHR) REVIEW: THE 6007983 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) 4902137 VERSION 37 MANUFACTURED IN THE LINE M14, ON 02/JUL/2024, WITH A TOTAL OF (B)(4) UNITS. WELDING THE LOT 4F05590 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34, MACHINE LS06 - LS07, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4F05592 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34, MACHINE LS24, LS25, WITH A TOTAL OF (B)(4) UNITS. GLUING CONNECTOR: THE LOT 4F02634 WAS GLUED ACCORDING TO THE WI VERSION 37, MACHINE PEGADO 3, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4F05599 WAS GLUED ACCORDING TO THE WI VERSION 37, MACHINE PEGADO 3, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4F05598 WAS GLUED ACCORDING TO THE WI VERSION 37, MACHINE PEGADO 3, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4F05600 WAS GLUED ACCORDING TO THE WI VERSION 37, MACHINE PEGADO 3, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WERE IDENTIFIED; NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 30/MAY/2025 AGAINST MALFUNCTION CODE OCCLUSION AT INFUSION SITE (E.G. OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED) (SPECIFIC CAUSE NOT IDENTIFIED) AND LOT 6007983, AND ANOTHER 1 COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CAPA PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOCKAGE WAS AT THE SITE. 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
    1421264 TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002833 6007983

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female