BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD US CATHENA 20GX1.00IN STRAIGHT BC

    MDR report key: 21496931 · Received February 28, 2025

    Report

    Report Number
    2243072-2025-00169
    Event Type
    Malfunction
    Date Received
    February 28, 2025
    Date of Event
    February 12, 2025
    Report Date
    April 30, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    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

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

    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. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    NO SAMPLES OR PHOTOS WERE RETURNED FOR INVESTIGATION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD US CATHENA 20GX1.00IN STRAIGHT BC LEAKED. IT WAS REPORTED BY CUSTOMER THAT THE FAILURE OF CATHENA VALVE IMMEDIATELY AFTER PLACEMENT. FAILURE OF CATHENA VALVE IMMEDIATELY AFTER PLACEMENT. CUSTOMER RESPONDED ON (B)(6) 2025. COULD YOU PLEASE PROVIDE THE BRIEF DESCRIPTION OF THE ISSUE? THE NURSES REPORTED LEAKING OF BLOOD THROUGH THE CATHENA VALVE IMMEDIATELY AFTER PLACING AN IV. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN THIS FORMAT MM-DD-YYYY FOR ALL 3 EVENTS? 2/12/2025 FOR ALL 3 EVENTS. COULD YOU PLEASE CONFIRM WHETHER EACH OF THE THREE INCIDENTS INVOLVES A DIFFERENT PATIENT? ALL OF THESE WERE WITH SEPARATE PATIENTS. ONE IN L&D, ONE IN SAME DAY SURGERY AND ONE IN THE ED.

    Description of Event or Problem · 0

    MATERIAL#: 386803, BATCH#: 4237744. IT WAS REPORTED BY CUSTOMER THAT THE FAILURE OF CATHENA VALVE IMMEDIATELY AFTER PLACEMENT. FAILURE OF CATHENA VALVE IMMEDIATELY AFTER PLACEMENT. CUSTOMER RESPONDED ON (B)(6) 2025. COULD YOU PLEASE PROVIDE THE BRIEF DESCRIPTION OF THE ISSUE? THE NURSES REPORTED LEAKING OF BLOOD THROUGH THE CATHENA VALVE IMMEDIATELY AFTER PLACING AN IV. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN THIS FORMAT MM-DD-YYYY FOR ALL 3 EVENTS? 2/12/2025 FOR ALL 3 EVENTS. COULD YOU PLEASE CONFIRM WHETHER EACH OF THE THREE INCIDENTS INVOLVES A DIFFERENT PATIENT? ALL OF THESE WERE WITH SEPARATE PATIENTS. ONE IN L&D, ONE IN SAME DAY SURGERY AND ONE IN THE EMERGENCY DEPARTTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414635 BD US CATHENA 20GX1.00IN STRAIGHT BC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 4237744

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown