BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 20627446 · Received November 7, 2024

    Report

    Report Number
    3003442380-2024-30637
    Event Type
    Malfunction
    Date Received
    November 7, 2024
    Date of Event
    September 20, 2024
    Report Date
    November 7, 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

    INITIAL AND FINAL (B)(4) - DEVICE 2 OF 3.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2024-30637. 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. PER REVISION 21 OF PROCEDURE (B)(4), A CHILD INVESTIGATION IS NOT REQUIRED TO DOCUMENT THE DEVICE HISTORY RECORD (DHR) REVIEW FOR A TYPE 2 REPORTABLE COMPLAINT. HOWEVER, THE CHILD WAS CREATED TO ALLOW THE PARENT RECORD TO ADVANCE TO REVIEW AND SUMMARY. SINCE IT WAS CREATED, THE DEVICE HISTORY RECORD (DHR) REVIEW WAS DOCUMENTED WITHIN THE CHILD. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6000886, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6000886 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 91 AND MANUFACTURED IN THE LINE INSET 7 ON 15/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. GLUE-CONNECTOR LOT THE LOT 3E01895 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 AND MANUFACTURED IN THE MACHINE MP03 ON 14/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3E01896 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 AND MANUFACTURED IN THE MACHINE MP03 ON 14/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3E02537 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 AND MANUFACTURED IN THE MACHINE MP03 ON 13/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) REVEALED THAT DURING OUTGOING TEST 6, ONE EXTENDED SAMPLING WAS RAISED: ONE FOR TUBE ATTACHED TO THE TAPE. ONE EXTENDED SAMPLING WAS ACCEPTED. THEREFORE, THE DEVICE HISTORY RECORD (DHR) CONFIRMS THAT ALL REQUIRED TESTS RELATED TO THE PROCESS WERE COMPLETED AND MET THE APPLICABLE REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: ONE EXTENDED WAS RAISED DURING THE PROCESS UNRELATED TO THE MALFUNCTION REPORTED, THEREFORE, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT 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 PATIENT FACED 3 INFUSION SETS CANNULA FELL OUT OF BODY EVENTS ON (B)(6) 2024. PATIENT ALSO EXPERIENCED REDNESS AT INFUSION SET INSERTION SITE.THE INFUSION SETS HAS BEEN USED FOR 8-9 HOURS. 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
    198874 TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL A/S 1002833 6000886 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female