BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 21533895 · Received March 6, 2025

    Report

    Report Number
    3003442380-2025-02847
    Event Type
    Malfunction
    Date Received
    March 6, 2025
    Date of Event
    January 27, 2025
    Report Date
    September 17, 2025
    Manufacturer
    UNOMEDICAL UM-D
    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 6003267, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. · DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003267 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 94 AND PACKAGING IN THE MULTIVAC M10 ON 12-SEP-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: WELDING OF THE LOT 3J01302 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 32 AND MANUFACTURED IN THE MACHINE LS11-LS24-LS25, ON 11-SEP-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: WELDING OF THE LOT 3J01301 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 32 AND MANUFACTURED IN THE MACHINE LS11-LS24-LS25, ON 10-SEP-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF CONNECTOR OF THE LOT 3J01293 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 35 AND MANUFACTURED IN THE LINE 03, ON 11-SEP-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF CONNECTOR OF THE LOT 3J01198 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 35 AND MANUFACTURED IN THE LINE 03, ON 09-SEP-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF CONNECTOR OF THE LOT 3J01199 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 35 AND MANUFACTURED IN THE LINE 03, ON 10-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: 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 THE UNITED STATES. IT WAS REPORTED THAT PATIENT EXPERIENCED EVENT OF INFUSION SET NEEDLE BENT AFTER INSERTIONON (B)(6) 2025. THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN 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
    798510 TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL UM-D 1002833 6003267 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male