BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 19605039 · Received June 25, 2024

    Report

    Report Number
    3003442380-2024-10155
    Event Type
    Malfunction
    Date Received
    June 25, 2024
    Date of Event
    April 29, 2024
    Report Date
    November 26, 2025
    Manufacturer
    UNOMEDICAL A/S
    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

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR. CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4. 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. REVISION 21 OF PROCEDURE (B)(4), A CHILD INVESTIGATION IS NOT REQUIRED TO DOCUMENT THE 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 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 5407715, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003983 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 88 AND MANUFACTURED IN THE MACHINE MULTIVAC 10 AND MULTIVAC 14 ON 12/DEC/2022, WITH A TOTAL OF (B)(4) UNITS. GLUE-TUBING LOT: THE LOT 5411130 WAS MANUFACTURED ACCORDING TO THE WI VERSION 54 AND MANUFACTURED IN THE MACHINE SC08 ON 02/DEC/2022, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5411131 WAS MANUFACTURED ACCORDING TO THE WI VERSION 54 AND MANUFACTURED IN THE MACHINE SC08 ON 02/DEC/2022, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5406406 WAS MANUFACTURED ACCORDING TO THE WI VERSION 54 AND MANUFACTURED IN THE MACHINE SC05 AND SC06 ON 09/DEC/2022, 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. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT MALFUNCTION CODE, THEREFORE, 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.

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1896202 - MDR 3003442380-2024-10155- DEVICE 1 OF 3

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6) IT WAS REPORTED THAT PATIENT EXPERIENCED THE BLOCKAGE IS LOCATED IN THE TUBING. THE INFUSION SET WAS NOT USED FOR MORE THAN 48 HOURS. THE PATIENT REPLACED THE INFUSION SET AND INSULIN WAS RESUMED SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142633 TRUSTEEL UNO CONTACT DETACH G29 80/8TCAP 10PK INT FPA UNOMEDICAL A/S 1002836 5407715 05705244018518

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male