BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 22173205 · Received June 10, 2025

    Report

    Report Number
    3003442380-2025-10441
    Event Type
    Malfunction
    Date Received
    June 10, 2025
    Date of Event
    May 10, 2025
    Report Date
    September 17, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018457
    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. · COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6003196, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. · DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003196 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 94 AND PACKAGING IN THE MULTIVAC M10 ON 07-SEP-2023, WITH A TOTAL OF (B)(4) UNITS. AN NON-CONFORMANCE (NC) 1737591 LEAK TEST FROM HEPA FILTERS OUT OF SPECIFICATION AT CLEAN ROOM 4 THE SUB-ASSEMBLY: GLUING OF TUBING OF THE LOT 3J00222 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 55 AND MANUFACTURED IN THE MACHINE SC05-SC06, ON 04-SEP-2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (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 SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: ONE NON-CONFORMANCE (NC) WAS RAISED DURING THE PROCESS UNRELATED TO THE MALFUNCTION REPORTED, THEREFORE, NO NON-CONFORMANCE (NC) RAISED RELATED TO COMPLAINT CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4), MDR 3003442380-2025-10454- DEVICE 1 OF 6.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED SIX INFUSION SET DETACHMENT EVENT ON 18 MAY-2025. THE SITE OF DETACHMENT WAS CONNECTOR. THE INFUSION SET WAS IN USE FOR 2 HOURS. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1654684 TRUSTEEL UNO CONTACT DETACH G29 80/6TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002834 6003196 05705244018457

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female