BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTA PLUS3 BLUE

    MDR report key: 23301564 · Received October 15, 2025

    Report

    Report Number
    9610847-2025-00375
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    October 10, 2025
    Report Date
    December 5, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE 2 PHOTOS 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 NO DEFECT COULD BE FOUND UPON VISUAL INSPECTION AND THE CONNECTIONS WERE TESTED WITH A BD SYRINGE AND BOTH PORTS CONNECTED CORRECTLY. BD COULD NOT DETERMINE A MANUFACTURING RELATED ROOT CAUSE SINCE THE REPORTED DEFECT WAS NOT CONFIRMED DURING THE EVALUATION OF THE SAMPLE. A MEMO HAS BEEN INCLUDED THAT DETAILS IMPORTANT USAGE TECHNIQUES. 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.

    Description of Event or Problem · 0

    CANNOT BE LOCKED WHEN DID THE INCIDENT OCCUR? DURING USE IT WAS REPORTED THAT THE DWH CANNOT BE LOCKED IN PLACE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2020321 CONNECTA PLUS3 BLUE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 4304870

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown