BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 21052578 · Received January 2, 2025

    Report

    Report Number
    3003442380-2024-35733
    Event Type
    Malfunction
    Date Received
    January 2, 2025
    Date of Event
    November 29, 2024
    Report Date
    June 14, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244018488
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 6004161 HAVE ALREADY BEEN PREVIOUSLY TESTED FOR VISUAL INSPECTION AND FLOW IN THE 1860599 ON 06/MAY/2024. ALL TESTS WERE FOUND WITHIN SPECIFICATIONS AS PER 1860599 TEST REPORT. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE BATCH RECORD 6004161 WAS VERIFIED AND IT WAS FOUND WITHIN SPECIFICATIONS. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6004161 WAS MANUFACTURED ACCORDING TO THE DOCUMENT VERSION 78 ON THE PACKING PROCESS IN THE MACHINE MULTIVAC 10, ON 28/APR/2024, WITH A TOTAL OF (B)(4) UNITS. GLUE-CONNECTOR: THE LOT 3K05747 WAS MANUFACTURED ACCORDING TO THE DOCUMENT (B)(4) VERSION 36 ON THE PACKING PROCESS IN THE MACHINE MP03, ON 06/NOV/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, NOR MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 30/MAY/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 6004161 AND FOUR MORE COMPLAINTS 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 OTHER 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 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 THE PATIENT FACED AN INFUSION SET OCCLUSION EVENT ON (B)(6) 2024. OCCLUSION WAS LOCATED AT THE SITE. BLOOD GLUCOSE LEVELS WERE REPORTED TO BE HIGH DURING THE EVENT. PATIENT TOOK CORRECTION INJECTIONS VIA MULTIPLE DAILY INJECTIONS TO ADDRESS THE EVENT. 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
    1911003 TRUSTEEL UNO CONTACT DETACH G29 60/8TCAP 10PK INT FPA UNOMEDICAL UM-D 1002835 6004161 05705244018488

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female