BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    US CATHENA 20GX1.00IN STRAIGHT BC

    MDR report key: 23555799 · Received November 14, 2025

    Report

    Report Number
    2243072-2025-01401
    Event Type
    Malfunction
    Date Received
    November 14, 2025
    Date of Event
    November 6, 2025
    Report Date
    November 20, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903868629
    PMA / PMN Number
    K220584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE PHOTO SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF SAFETY SHIELD ACTIVATION FAILURE WAS NOT CONFIRMED UPON INSPECTION OF THE PHOTO. BD CANNOT CONFIRM THE CAUSE OF THE FAILURE TO OUR MANUFACTURING PROCESS SINCE NO PHYSICAL SAMPLE WAS RETURNED. 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. ON THURSDAY, NOVEMBER 6TH, ONE OF OUR STAFF MEMBERS EXPERIENCED THE SAME ISSUE WE¿VE BEEN HAVING WITH THE DEFECTIVE IVS. THE PROBLEM OCCURRED AGAIN THIS MORNING, AS SHOWN IN THE PHOTO. THE LOT NUMBER INVOLVED IS 5081568.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2805090 US CATHENA 20GX1.00IN STRAIGHT BC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 5081568 00382903868629

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown