BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK

    MDR report key: 22325203 · Received June 25, 2025

    Report

    Report Number
    3003442380-2025-10995
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    May 27, 2025
    Report Date
    July 4, 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
    003

    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 6001251 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE COMPLAINT (B)(4) ON 20-MAY- 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 (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001251 WAS PACKAGING ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 43, IN THE MULTIVAC M07, ON 29/APR/2023, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING: THE LOT 3E00756 WAS GLUED ACCORDING TO THE WI VERSION 21, MACHINE 07, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3D00062 WAS GLUED ACCORDING TO THE WI VERSION 21, MACHINE 07, 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/JUN/2025 AGAINST MALFUNCTION CODE LEAKAGE FROM CONNECTION BETWEEN THE TUBING CONNECTOR AND THE INFUSION SET (CANNULA PART/BASE PIECE) AND LOT 6001251 AND NO MORE COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON THE VISUAL INSPECTION FOR REFERENCE SAMPLES, NO HARM REPORTED, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION AND REPORTED MALFUNCTION. 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 BRAZIL. IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET LEAKAGE ON (B)(6) 2025 AT CATHETER WITH THE CANNULA. 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
    2063290 ACCU-CHEK FLEXLINK AC FLEXLINK CANNULA 10 10PCS. FPA UNOMEDICAL DEVICES S.A. DE C.V. 04626575001 6001251

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female