BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 22093649 · Received May 28, 2025

    Report

    Report Number
    3003442380-2025-09404
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    February 25, 2025
    Report Date
    May 28, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K143446
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 6003908 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE (B)(4) ON 08/APR/2025. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND LEAK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT DATABASE (B)(4) COMPLAINT TEST REPORT. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003908 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 15 MANUFACTURED IN THE LINE/MACHINE MULTIVAC 07, ON 16/NOV/2023, WITH A TOTAL OF (B)(4) UNITS. DHR CANNULA: THE LOT 3L01884 WAS MANUFACTURED ACCORDING TO THE WI VERSION 36 MANUFACTURED IN THE LINE/MACHINE 02, ON 13/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, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 26/MAY/2025 AGAINST MALFUNCTION CODE LEAKAGE FROM INFUSION SITE (CANNULA BASE PART/CANNULA) (SPECIFIC CAUSE NOT IDENTIFIED) AND LOT 6003908 AND OTHER COMPLAINT HAS 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, AND ANOTHER 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 BRAZIL. IT WAS REPORTED THAT THE PATIENT FACED EVENT OF LEAKAGE OF CANNULA ON (B)(6) 2025. THE SITE WAS PATIENT'S ABDOMEN. 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
    1014363 ACCU-CHEK FLEXLINK PLUS INFUSION SET ACCU-CHEK FLEXLINK CANNULA 6 10 PCS FPA UNOMEDICAL DEVICES S.A. DE C.V. 06593941001 6003908

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female