BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA

    MDR report key: 20894245 · Received December 10, 2024

    Report

    Report Number
    1710034-2024-01461
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    August 27, 2024
    Report Date
    January 31, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835317
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS OF LATE PHOTO SAMPLE: THE COMPLAINT OF A DAMAGED EXTENSION TUBING WAS CONFIRMED; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED FROM THE THREE PHOTOGRAPHS THAT WERE PROVIDED FOR INVESTIGATION. ONE PHOTO SHOWED A 24G NEXIVA DEVICE WITH EVIDENCE OF USE. A TRANSPARENT DRESSING WAS OBSERVED ON THE DEVICE. THE NEEDLE HAD BEEN REMOVED FROM THE CATHETER AND WHAT APPEARED TO BE BLOOD RESIDUE WAS OBSERVED THROUGHOUT THE CATHETER AND EXTENSION TUBING. THE LUER ADAPTER WAS NOT CONNECTED TO THE END OF THE EXTENSION TUBE. IT COULD NOT BE DETERMINED IF THE TUBING WAS FRACTURED, CUT, OR INTACT. A REVIEW OF THE INSPECTION RECORDS AND QUALITY/MANUFACTURING CONTROLS FOR THE IMPLICATED LOT INDICATED NO ISSUES WITH THE MANUFACTURING PROCESS. MANUFACTURING CONTROLS ARE IN PLACE TO MITIGATE THE OCCURRENCE OF THIS TYPE OF FAILURE. THE COMPLAINT HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING RELATED ISSUES. 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

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383531 AND LOT NUMBER 4120706. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    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

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA CATHETER BROKE/DISCONNECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SUCCESSFUL INTRAVENOUS LINE (IV) START, BUT THE CATHETER BROKE/DISCONNECTED. BLEEDING NOTED AND IV NO LONGER CLEAN OR INTACT; HAD TO RESTART/RE-POKE THE PATIENT. (B)(6). PATIENT HAD TO BE RE-STUCK. (B)(6)2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1419471 BD NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4120706 00382903835317

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Unknown