BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    US CATHENA 20GX1.00IN STRAIGHT BC

    MDR report key: 23521830 · Received November 11, 2025

    Report

    Report Number
    2243072-2025-01374
    Event Type
    Malfunction
    Date Received
    November 11, 2025
    Date of Event
    October 24, 2025
    Report Date
    December 5, 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

    AS NO PHYSICAL OR PICTURE SAMPLE, OR VALID LOT NUMBER WAS PROVIDED FOR EVALUATION, BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THERE ARE CURRENT QUALITY CONTROLS IN PLACE TO DETECT THIS TYPE OF PRODUCT MALFUNCTION DURING THE PRODUCTION PROCESS. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    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

    MATERIAL # UNKNOWN, 386862 LOT # UNKNOWN, 5081568. IT WAS REPORTED BY CUSTOMER THAT SAFETY MECHANISM ON CATHENA CATHETER FAILED TO WORK. SAFETY MECHANISM ON CATHENA CATHETER FAILED TO WORK LEAVING AN EXPOSED NEEDLE AND FAILURE TO USE THE IV CATHETER. HAPPENED ON 2 SEPARATE PATIENTS, SAME ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1963227 US CATHENA 20GX1.00IN STRAIGHT BC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON UNKNOWN 00382903868629

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown