BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTA WHT 360DEG VALVE TB 105CM

    MDR report key: 23509470 · Received November 10, 2025

    Report

    Report Number
    9610847-2025-00410
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    October 27, 2025
    Report Date
    January 12, 2026
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IC
    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. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE PHOTO SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF SEPARATION OTHER COMPONENT WAS CONFIRMED UPON INSPECTION OF THE PHOTO. ANALYSIS OF THE SAMPLE SHOWED THAT THE SUBASSEMBLY IS DETACHED FROM THE EXTENSION TUBE. BD DETERMINED THAT THE CAUSE OF THE FAILURE WAS A BAD ASSEMBLY BY THE ASSEMBLY MACHINE. 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

    394971 WITH LOT 5032404. THEY HAVE EXPERIENCED X2 THAT THE CONNECTION HAS BROKEN.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2616054 CONNECTA WHT 360DEG VALVE TB 105CM INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 5032404

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown