BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD US CATHENA 18GX1.25IN STRAIGHT BC

    MDR report key: 21858935 · Received April 17, 2025

    Report

    Report Number
    2243072-2025-00529
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Date of Event
    March 31, 2025
    Report Date
    May 20, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903868650
    PMA / PMN Number
    K220584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. DUE TO A MANUFACTURING DEFECT, THERE IS POTENTIAL FOR A HOLE IN THE SEPTUM OF THE CATHENA 18- AND 20-GAUGE CATHETERS. THE HOLE MAY RESULT IN BLOOD LEAKAGE FROM THE SEPTUM DURING INSERTION. THE BLOOD LEAKAGE MAY CAUSE BLOOD EXPOSURE OR THE NEED FOR A SECOND IV TO BE PLACED. THE REPLACEMENT OF THE IV MAY RESULT IN A BRIEF DELAY IN THERAPY WHICH WOULD NOT BE EXPECTED TO RESULT IN AN ADVERSE EVENT. BD HAS IDENTIFIED ROOT CAUSE AND INITIATED CORRECTIVE ACTIONS TO PREVENT RECURRENCE OF THIS ISSUE.

    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

    IT WAS REPORTED THAT BD US CATHENA 18GX1.25IN STRAIGHT BC BLOOD LEAKS OUT OF CONTROL PLUG IT WAS REPORTED BY CUSTOMER THAT THE CATHENA BLOOD CONTROL NOT WORKING. ALLOWING FOR BLOOD RETURN UPON PLACING IV CATHETER. VERBATIM: CATHENA BLOOD CONTROL NOT WORKING. ALLOWING FOR BLOOD RETURN UPON PLACING IV CATHETER BD REP RESPONSE ON (B)(6) 2025 FOR (B)(4): 1. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. 2. IN (B)(4), THE LOT NUMBER WAS MENTIONED AS 4124016, BUT THE ATTACHED PRODUCT IMAGE SHOWS THE LOT NUMBER AS 4198480. COULD YOU PLEASE CONFIRM WHICH LOT IS EXPERIENCING THE REPORTED ISSUE, OR IF BOTH ARE AFFECTED? BOTH LOT NUMBERS ARE AFFECTED. CUSTOMER RESPONSE ON (B)(6) 2025. FOR (B)(4): 1. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1777081 BD US CATHENA 18GX1.25IN STRAIGHT BC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 4198480 00382903868650

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown