BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 22337683 · Received June 26, 2025

    Report

    Report Number
    3003442380-2025-11028
    Event Type
    Malfunction
    Date Received
    June 26, 2025
    Date of Event
    June 8, 2025
    Report Date
    September 9, 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: REVISION 21 OF (B)(4) DOES NOT REQUIRE A COMPLAINT THAT IS TYPE 2 REPORTABLE TO OPEN A CHILD INVESTIGATION. THIS CHILD INVESTIGATION WAS OPENED AGAINST A PREVIOUS REVISION OF (B)(4). COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6010590, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010590 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 98 AND PACKAGED IN THE MACHINE MULTIVAC 14 ON 06-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, WELDING OF THE LOT 4L03409 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 AND MANUFACTURED IN THE MACHINE LS06-LS07, ON 04-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, WELDING OF THE LOT 4L04888 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 AND MANUFACTURED IN THE MACHINE LS06-LS07, ON 03-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING CONNECTOR OF THE LOT 4M00753 WAS MANUFACTURED ACCORDING TO THE WI VERSION 37 AND MANUFACTURED IN THE MACHINE GLUING 3, ON 04-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING CONNECTOR OF THE LOT 4M01011 WAS MANUFACTURED ACCORDING TO THE WI VERSION 37 AND MANUFACTURED IN THE MACHINE GLUING 3, ON 05-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING CONNECTOR OF THE LOT 4M00754 WAS MANUFACTURED ACCORDING TO THE WI VERSION 37 AND MANUFACTURED IN THE MACHINE GLUING 3, ON 05-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING CONNECTOR OF THE LOT 4M01032 WAS MANUFACTURED ACCORDING TO THE WI VERSION 37 AND MANUFACTURED IN THE MACHINE GLUING 3, ON 06-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING CONNECTOR OF THE LOT 4M04169 WAS MANUFACTURED ACCORDING TO THE WI VERSION 37 AND MANUFACTURED IN THE MACHINE GLUING 3, ON 07-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING CONNECTOR OF THE LOT 4M00125 WAS MANUFACTURED ACCORDING TO THE WI VERSION 37 AND MANUFACTURED IN THE MACHINE GLUING 3, ON 02-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING CONNECTOR OF THE LOT 4M00126 WAS MANUFACTURED ACCORDING TO THE WI VERSION 37 AND MANUFACTURED IN THE MACHINE GLUING 3, ON 03-DEC-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING CONNECTOR OF THE LOT 4M00752 WAS MANUFACTURED ACCORDING TO THE WI VERSION 37 AND MANUFACTURED IN THE MACHINE GLUING 3, ON 03-DEC-2024, 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 WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION 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.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED STATES IT WAS REPORTED THAT THE PATIENT FACED AN 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
    1270763 TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002833 6010590 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female