BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC EXTENDED INFUSION SET

    MDR report key: 19544955 · Received June 16, 2024

    Report

    Report Number
    8021545-2024-01190
    Event Type
    Malfunction
    Date Received
    June 16, 2024
    Date of Event
    April 4, 2024
    Report Date
    October 16, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244022683
    PMA / PMN Number
    K210544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR WITH MANUFACTURING REPORT NUMBER (8021545-2024-01190), WAS SUBMITTED ON 16-JUN-2024. UPON COMPLETION OF THE INVESTIGATION, THE MANUFACTURING DATE WAS UPDATED AS 06-JUN-2023. 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 - COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4) THE BATCH 6001846. IN QUESTION WAS MANUFACTURED AT THE OSTED SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE 6001846 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) APPENDIX 1 BATCHCARD FOR PRODUCTION OF PACKAGING ROOM ON 06-JUN-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 WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. TEST RESULTS: NO PRODUCT WAS RETURNED. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION, 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

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: FRANCE.

    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 FRANCE ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT THAT INFUSION SET WAS LEAKING FROM CONNECTION. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582974 MEDTRONIC EXTENDED INFUSION SET UNO EWIS BLUE 60/6 HCAP 10PK INT FPA UNOMEDICAL A/S MMT-431A 6001846 05705244022683

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown