BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SINGLE PORT

    MDR report key: 19180832 · Received April 25, 2024

    Report

    Report Number
    1710034-2024-00351
    Event Type
    Malfunction
    Date Received
    April 25, 2024
    Date of Event
    March 27, 2024
    Report Date
    May 30, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835171
    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

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. E. EMAIL PROVIDED EXCEEDS CHARACTER LIMIT: (B)(6).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: DETAILS ADDED TO B5. INVESTIGATION RESULTS: THE COMPLAINT OF A LEAK AT THE SEPTUM WAS CONFIRMED AND THE CAUSE WAS DETERMINED TO BE MANUFACTURING RELATED. ONE 20G NEXIVA DEVICE FROM LOT #3220065 WAS PROVIDED FOR INVESTIGATION. WHAT APPEARED TO BE BLOOD RESIDUE WAS NOTED BETWEEN THE SEPTUM CANNISTER AND THE CATHETER ADAPTER. THE CANNISTER APPEARED TO BE DEFORMED AND DAMAGED, WHICH LIKELY OCCURRED DURING ASSEMBLY. THE APPROPRIATE MANUFACTURING PERSONNEL WERE NOTIFIED OF THIS COMPLAINT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA SINGLE PORT LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN INSERTING THE CATHETER AFTER REMOVING THE NEEDLE, THERE IS A FLOW OF BLOOD.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: NO HARM TO USERS. THE CATHETERS REMAINED FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160879 BD NEXIVA SINGLE PORT PERIPHERAL IV CAT HETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3220065 00382903835171

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown