BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 22164802 · Received June 9, 2025

    Report

    Report Number
    3003442380-2025-10406
    Event Type
    Malfunction
    Date Received
    June 9, 2025
    Date of Event
    April 20, 2025
    Report Date
    June 25, 2025
    Manufacturer
    UNOMEDICAL A/S
    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

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2025-10406. 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) WITH MALFUNCTION CODE LEAKAGE FROM CONNECTION BETWEEN THE TUBING CONNECTOR AND THE INFUSION SET (CANNULA PART/BASE PIECE). THE BATCH 6002999 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 03 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 02 FOR THE LEAKAGE FROM CONNECTION BETWEEN THE TUBING CONNECTOR AND THE INFUSION SET (CANNULA PART/BASE PIECE). COMPLAINT INVESTIGATION: TEST RESULTS: VISUAL TEST ACCORDING TO WI VERSION 3 ON REFERENCE SAMPLES, REFERENCE SAMPLES PASSED THE TEST. FUNCTIONAL (FLOW TEST) TEST ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, REFERENCE SAMPLES PASSED THE TEST. FUNCTIONAL (LEAK TEST) TEST ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, REFERENCE SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6002999 WAS PACKAGED ACCORDING TO THE WI VERSION 94, PACKAGED IN THE MACHINE MULTIVAC 10, ON 01/SEP/2023 WITH A TOTAL OF (B)(4) UNITS. WELDING DHR REVIEW: THE LOT 3H03319 WAS MANUFACTURED ACCORDING TO THE WI VERSION 32, MANUFACTURED IN THE MACHINE LS24-LS25-LS11, ON 30/AUG/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3H03921 WAS MANUFACTURED ACCORDING TO THE WI VERSION 32, MANUFACTURED IN THE MACHINE LS24-LS25-LS11, ON 01/SEP/2023 WITH A TOTAL OF (B)(4) UNITS. GLUE CONNECTOR DHR REVIEW: THE LOT 3H03296 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35, MANUFACTURED IN THE MACHINE GLUING 3, ON 28/AUG/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3H03297 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35, MANUFACTURED IN THE MACHINE GLUING 3, ON 29/AUG/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3H03319 WAS MANUFACTURED ACCORDING TO THE WI VERSION 32, MANUFACTURED IN THE MACHINE LS24-LS25-LS11, ON 30/AUG/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3H04831 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35, MANUFACTURED IN THE MACHINE GLUING 3, ON 31/AUG/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3H03918 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35, MANUFACTURED IN THE MACHINE GLUING 3, ON 01/SEP/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3J00210 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35, MANUFACTURED IN THE MACHINE GLUING 3, ON 01/SEP/2023 WITH A TOTAL OF (B)(4) UNITS. TRENDING: A QUERY WAS RUN IN DATABASE ON 25/JUN/2025 AGAINST MALFUNCTION CODE EVALUATED LEAKAGE FROM CONNECTION BETWEEN THE TUBING CONNECTOR AND THE INFUSION SET (CANNULA PART/BASE PIECE) AND LOT 6002999 AND OTHER 1 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: NO DEFECT ON TESTS FOR REFERENCE SAMPLES RELATED TO THE COMPLAINT, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, OTHER 1 COMPLAINT RECEIVED ON 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.

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4). DEVICE 1 OF 3.

    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 THE PATIENT FACED THREE INFUSION SETS TUBING LEAKAGE EVENTS ON (B)(6) 2025 AT COUPLING HOUSING. PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333509 TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL A/S 1002833 6002999 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male