BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 22083867 · Received May 26, 2025

    Report

    Report Number
    3003442380-2025-09430
    Event Type
    Malfunction
    Date Received
    May 26, 2025
    Date of Event
    February 11, 2025
    Report Date
    May 23, 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 INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED. THE BATCH 6001251 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2 FOR THE CODE LEAKAGE FROM INFUSION SITE (SPECIFIC CAUSE NOT IDENTIFIED) COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. TEST RESULTS: VISUAL TEST ACCORDING TO WI VERSION 3 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST AIR FLOW ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: PACKAGING: THE LOT 6001251 WAS PACKAGING ACCORDING TO THE WI VERSION 43, IN THE MULTIVAC M07, ON 29/ABR/2024, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY CANNULA: THE LOT 3C03352 WAS ASSEMBLED ACCORDING TO WI 4905170 VERSION 35 ON-LINE INSPECTION FOR ASSEMBLY FLEX SET ON 31/MAR/ 2023 IN LINE 2, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3D00053 WAS ASSEMBLED ACCORDING TO WI 4905170 VERSION 35 ON-LINE INSPECTION FOR ASSEMBLY FLEX SET ON 28 /ABR /2023 IN LINE 2, 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 20/MAY/2025 AGAINST MALFUNCTION CODE LEAKAGE FROM INFUSION SITE (SPECIFIC CAUSE NOT IDENTIFIED) AND LOT 6001251 AND NO 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, ONLY ONE 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 AN EVENT OF LEAKAGE OF CANNULA ON (B)(6) 2025. THE SITE WAS ABDOMEN AND FLANKS. 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
    990508 ACCU-CHEK FLEXLINK PLUS INFUSION SET AC FLEXLINK CANNULA 10 10PCS. FPA UNOMEDICAL DEVICES S.A. DE C.V. 04626575001 6001251

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male