BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 22747113 · Received August 8, 2025

    Report

    Report Number
    3003442380-2025-12654
    Event Type
    Malfunction
    Date Received
    August 8, 2025
    Date of Event
    October 31, 2024
    Report Date
    June 27, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244018518
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED FOR THE MALFUNCTION CODE OCCLUSION AT INFUSION SITE (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED) (SPECIFIC CAUSE NOT IDENTIFIED). THE BATCH 6004736 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. TEST RESULTS: VISUAL TEST ACCORDING TO WORK INSTRUCTION (WI) VERSION 3.0 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL FLOW TEST 1 ACCORDING TO WI VERSION 2.0 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: PACKING THE LOT 6004736 WAS MANUFACTURED ACCORDING TO THE WI VERSION 95 AND PACKAGING IN THE MULTIVAC 14, ON 13/DIC/202, WITH A TOTAL OF (B)(4) UNITS. WELDING THE LOT[?]3M01206 WAS MANUFACTURED ACCORDING TO THE WI VERSION 33 WELDING IN THE MACHINE LS24, LS25 & LS511 ON 13/DIC/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3M01415 WAS MANUFACTURED ACCORDING TO THE WI VERSION 33 WELDING IN THE MACHINE LS24, LS25 & LS511 ON 16/DIC/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3M02444 WAS MANUFACTURED ACCORDING TO THE WI VERSION 33 WELDING IN THE MACHINE LS506 & LS507, ON 17/DIC/2023, WITH A TOTAL OF (B)(4) UNITS. GLUING OF CONNECTOR THE LOT 3M01197 WAS MANUFACTURED ACCORDING TO THE WI VERSION 36 IN THE GLUING OF CONNECTOR IN THE MACHIN GLUING 3, ON 12/DIC/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3M01205 WAS MANUFACTURED ACCORDING TO THE WI VERSION 36 IN THE GLUING OF CONNECTOR IN THE MACHIN GLUING 3, ON 16/DIC/2023, 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 WERE IDENTIFIED RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 24/MAR/2025 AGAINST MALFUNCTION CODE OCCLUSION AT INFUSION SITE (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED) (SPECIFIC CAUSE NOT IDENTIFIED) AND LOT 6004736 AND ANOTHER 1 COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO HARM, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, ANOTHER 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.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2024. THE BLOCKAGE WAS AT THE SITE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233371 TRUSTEEL UNO CONTACT DETACH G29 80/8TCAP 10PK INT FPA UNOMEDICAL UM-D 1002836 6004736 05705244018518

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female