BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 22661365 · Received July 30, 2025

    Report

    Report Number
    3003442380-2025-11964
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    July 7, 2025
    Report Date
    July 25, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018426
    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 INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED. THE BATCH 6010013 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3 FOR THE STEEL CANNULA IS FOUND BENT UPON REMOVAL FROM INFUSION SITE. TEST RESULTS: VISUAL TEST ACCORDING TO WI VERSION 3 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010013 WAS MANUFACTURED ACCORDING TO THE WI VERSION 98 AND PACKAGING IN THE MACHINE 14, ON 17/NOV/2024, WITH A TOTAL OF (B)(4) UNITS. WELDING: THE LOT 4K02960 WAS ASSEMBLED ACCORDING TO THE WI VERSION 34 ON-LINE INSPECTION FOR MACHINE LS24 AND LS25 ON 16-NOV-2024, WITH A TOTAL OF (B)(4) UNITS EACH. THE LOT 4K02958 WAS ASSEMBLED ACCORDING TO THE WI VERSION 34 ON-LINE INSPECTION FOR MACHINE LS07 AND LS06 ON 15-NOV-2024, WITH A TOTAL OF (B)(4) UNITS EACH. GLUING CONNECTOR: THE LOT 4K05773 WAS GLUED ACCORDING TO THE WI VERSION 37, LINE 03 ON 16-NOV-2024, WITH A TOTAL OF (B)(4) UNITS EACH. THE LOT 4K05774 WAS GLUED ACCORDING TO THE WI VERSION 37, LINE 03 ON 16-NOV-2024, WITH A TOTAL OF (B)(4) UNITS EACH. THE LOT 4K05771 WAS GLUED ACCORDING TO THE WI VERSION 37, LINE 3 ON 13-NOV-2024, WITH A TOTAL OF (B)(4) UNITS EACH. MOULDING: THE LOT 4K05749 WERE MOULDING ACCORDING TO WI VERSION 36, MACHINE LS18 ON 15- NOV-2024, WITH A TOTAL OF (B)(4) UNITS EACH. THE LOT 4K05743 WERE MOULDING ACCORDING TO WI VERSION 36, MACHINE LS19 ON 15- NOV-2024, WITH A TOTAL OF (B)(4) UNITS EACH. THE LOT 4K05738 WERE MOULDING ACCORDING TO WI VERSION 36, MACHINE LS14 ON 15- NOV-2024, WITH A TOTAL OF (B)(4) UNITS EACH. THE LOT 4K02919 WERE MOULDING ACCORDING TO WI VERSION 36, MACHINE LS18 ON 12- NOV-2024, WITH A TOTAL OF (B)(4) UNITS EACH. 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 RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 24/JUL/2025 AGAINST MALFUNCTION CODE STEEL CANNULA IS FOUND BENT UPON REMOVAL FROM INFUSION SITE AND LOT 6010013 AND NO OTHER COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT NUMBER AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: 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 CORRECTIVE AND PREVENTIVE ACTION (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 NEW ZEALAND. IT WAS REPORTED THAT PATIENT FACED INFUSION SET NEEDLE WAS BENT ON (B)(6) 2025. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. 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
    514610 TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002833 6010013 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown