BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTA PLUS3 16CM WHITE

    MDR report key: 23016582 · Received September 10, 2025

    Report

    Report Number
    9610847-2025-00305
    Event Type
    Malfunction
    Date Received
    September 10, 2025
    Date of Event
    September 4, 2025
    Report Date
    December 4, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE 1 PHOTO AND 2 PHYSICAL SAMPLES SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF CONNECTION ISSUES WAS NOT CONFIRMED UPON INSPECTION OF THE SAMPLES. ANALYSIS OF THE SAMPLE SHOWED THAT THERE WAS NO DEFECT OBSERVED IN THE PHOTO AND UPON EVALUATION OF THE PHYSICAL SAMPLES, NO DEFECT WAS FOUND AND A BD SYRINGE WAS CONNECTED AT EACH PORT AND NO PROBLEM WAS FOUND IN THE CONNECTIONS. BD COULD NOT DETERMINE A MANUFACTURING RELATED ROOT CAUSE SINCE THE REPORTED DEFECT WAS NOT CONFIRMED DURING THE EVALUATION OF THE SAMPLE. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONNECTA PLUS3 16CM WHITE-LOOSE CONNECTION / DISCONNECTION. 3-WAY FAUCETS WITH THE SAME REF NUMBER HAVE CHANGED PACKAGING. ALSO NOTICE THAT THE PRODUCT ITSELF IS MADE DIFFERENTLY, BUT LESS PLASTIC AND FLATTER INTERNAL THREAD IN THE FEMALE PART. IT ADHERES LESS WELL AND HAS SEVERAL TIMES COME LOOSE OR CANNOT BE ATTACHED TO THE CRANE BLOCK OR EXTENSION HOSE. GREAT RISK FOR US AS THIS CONNECTION IS IN OUR ECMO SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2061081 CONNECTA PLUS3 16CM WHITE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 4304907

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown