BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 21845938 · Received April 16, 2025

    Report

    Report Number
    3003442380-2025-06186
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    March 16, 2025
    Report Date
    July 2, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    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 REFERENCE SAMPLES FOR THE LOT 6009885 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE 2142413 ON 05-APR-2024. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR CLICK AND STATIC PULL OF TUBING-TUBING CONNECTOR. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6009885 WAS MANUFACTURED ACCORDING TO THE WI VERSION 98 AND PACKAGING IN THE MACHINE 14, ON 19-OCT-2024, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING: THE LOT 4K01300 WAS GLUED ACCORDING TO THE WI VERSION 65, MACHINE SC05 AND SC06, ON 18-OCT-2024 WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K01372 WAS GLUED ACCORDING TO THE WI VERSION 65, MACHINE SC05 AND SC06, ON 18-OCT-2024 WITH A TOTAL OF (B)(4) UNITS THE LOT 4K02980 WAS GLUED ACCORDING TO THE WI VERSION 65, MACHINE SC08, ON 17-OCT-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 WERE IDENTIFIED; NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 02/JUL/2025 AGAINST MALFUNCTION CODE TUBING DETACHED FROM TUBING-TUBING CONNECTOR AND LOT 6009885 AND ONE MORE COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: 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 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 EXPERIENCED THAT INFUSION SET TUBING DETACHED FROM CONNECTOR ON (B)(6) 2025. THE INFUSION SET WAS IN USE FOR ONE DAY. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION WAS 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
    2349935 TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL UM-D 1002833 6009885

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female