BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SINGLE PORT

    MDR report key: 21119619 · Received January 9, 2025

    Report

    Report Number
    1710034-2024-01595
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    December 20, 2024
    Report Date
    February 26, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835126
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT OF DETACHED EXTENSION TUBING WAS CONFIRMED, AND THE CAUSE APPEARED TO BE MANUFACTURING RELATED. ONE 22GA NEXIVA UNIT FROM LOT: 4212434 WAS PROVIDED FOR INVESTIGATION. THE TIP OF THE EXTENSION TUBING WAS NOT POSITIONED WITHIN THE CATHETER ADAPTER; HOWEVER, THE EXTERNAL SURFACE OF THE TUBING WAS BONDED WITH ADHESIVE TO THE EXTERNAL SURFACE OF THE CATHETER ADAPTER, WHICH WOULD ALLOW FLUID TO LEAK. THE APPROPRIATE MANUFACTURING PERSONNEL WERE NOTIFIED OF THIS COMPLAINT. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA 22 GA X 1 IN SINGLE PORT TUBING SEPARATED FROM HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHAT HAPPENED? EXTENSION TUBING BECAME DISCONNECTED AFTER INSERTION. WAS IT USED ON A PATIENT. - YES. ANY ISSUES WITH THE PATIENT. ¿ CATHETER HAD TO BE REMOVED AND REINSERTED /BLOOD BACKED UP AND LEAKED OUT THE TUBING, BLOOD EXPOSURE RISK TO THE STAFF AND PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224804 BD NEXIVA SINGLE PORT PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4212434 00382903835126

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown