BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    US CATHENA 20GX1.00IN STRAIGHT BC

    MDR report key: 23523188 · Received November 11, 2025

    Report

    Report Number
    2243072-2025-01373
    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. . VERBATIM: 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
    2525179 US CATHENA 20GX1.00IN STRAIGHT BC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 5081568 00382903868629

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown