BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUSTEEL

    MDR report key: 20368462 · Received October 4, 2024

    Report

    Report Number
    3003442380-2024-26785
    Event Type
    Injury
    Date Received
    October 4, 2024
    Date of Event
    August 28, 2024
    Report Date
    July 29, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018426
    PMA / PMN Number
    K041545
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2024-26785. CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4. 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) HAS BEEN EVALUATED FOR THE MALFUNCTION CODE NO MALFUNCTION BASED ON COMPLAINT INFORMATION. THE BATCH 6005556 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. TEST RESULTS: COMPLAINT INVESTIGATION: THE REFERENCE SAMPLES CANNOT BE TESTED BECAUSE THERE WAS NO SPECIFIC MALFUNCTION TO INVESTIGATE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT6005556 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 93 PACKAGING IN THE MULTIVAC10, ON14/FEB/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 RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 29-JUL-2025 AGAINST HARM CODE INFECTION REQUIRES PRESCRIPTIVE TREATMENT E G ORAL ANTIBIOTICS, MALFUNCTION CODE NO MALFUNCTION DESCRIBE AND LOT 6005556 AND NO MORE COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT, HARM CODE AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, ONLY ONE COMPLAINT RECEIVED ON THE LOT IN QUESTION AND HARM CODE, THE TEST ON REFERENCE SAMPLES WERE NOT TESTED SINCE A NO MALFUNCTION RELATED TO THE INFUSION SET WAS REPORTED, THEREFORE 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 THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED THREE INFUSION SET INSERTION SITE ISSUES EVENT 28-AUG-2024, 31-AUG-2024 AND 04-SEP-2024. THERE WAS REDNESS, IRRIATION, PAIN, INFECTION AND SWELLING AT INSERTION SITE. THE INFUSION SET WAS IN USE FOR APPROXIMATELY 24 HOURS. THE PATIENT WENT TO EMERGENCY CARE AND GOT TREATED WIITH ANTIBIOTICS. 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
    713238 TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL A/S 1002833 6005556 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female