BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA MAXZERO

    MDR report key: 24079426 · Received January 15, 2026

    Report

    Report Number
    1710034-2026-00017
    Event Type
    Malfunction
    Date Received
    January 15, 2026
    Date of Event
    December 23, 2025
    Report Date
    February 19, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835560
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    501

    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.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT THAT THE SEPTUM SEPARATED FROM THE CATHETER ADAPTER WAS CONFIRMED; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. TWO PHOTOGRAPHS AND TWO REPRESENTATIVE 20G NEXIVA DEVICES WERE PROVIDED FOR INVESTIGATION. NO DAMAGE OR DEFECTS WERE IDENTIFIED ON THE REPRESENTATIVE SAMPLES. THE PHOTOGRAPHS SHOWED A USED 20G NEXIVA DEVICE WHERE THE SEPTUM AND CANISTER ASSEMBLY SEPARATED FROM THE CATHETER ADAPTER, WHICH ALLOWED FLUID TO LEAK FROM THE DEVICE. NO SPECIFIC DAMAGE OR DEFECTS ASSOCIATED WITH THE MANUFACTURING OR ASSEMBLY PROCESS COULD BE IDENTIFIED FROM THE PHOTOGRAPHS. AS THE DEVICE IN THE PHOTOGRAPH HAD BEEN USED, IT COULD NOT BE DETERMINED WITH CERTAINTY WHETHER THE DAMAGE ORIGINATED DURING MANUFACTURING OR USE OF THE DEVICE. AS THE CUSTOMER REPORTED THAT THE DAMAGE OCCURRED DURING CT CONTRAST INFUSION, OVERPRESSURIZATION MAY HAVE BEEN A CONTRIBUTING FACTOR. THE INSTRUCTIONS FOR USE (IFU) STATE, "AVOID KINKING OR OBSTRUCTING CATHETER DURING POWER INJECTION. WARNING: IN THE EVENT OF AN OCCLUSION, POWER INJECTOR PRESSURE-LIMITING FEATURES MAY NOT PREVENT CATHETER FAILURE." THE IFU ALSO STATES, "THE 22-18 GA (0.9-1.3 MM) DEVICES ARE SUITABLE FOR USE WITH POWER INJECTORS SET TO A MAXIMUM PRESSURE OF 300 PSI (2068 KPA) WHEN ACCESS PORTS NOT SUITABLE FOR USE WITH POWER INJECTORS ARE REMOVED." THE AFFECTED IV CATHETER WAS NOT PROVIDED FOR INVESTIGATION. THERE WERE NO OTHER COMPLAINTS FROM THE IMPLICATED LOT AND A REVIEW OF THE INSPECTION RECORDS AND QUALITY/MANUFACTURING CONTROLS FOR THE IMPLICATED LOT INDICATED NO RELATED ISSUES WITH THE MANUFACTURING PROCESS. 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. COMPLAINTS RECEIVED ABOUT THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE DATA COLLECTED FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    BRIEF DESCRIPTION OF INCIDENT: PT HAD NSL FOR CT - WAS INFUSING (MESS AND FLUSH). DURING INFUSION OF CONTRAST NSL PLUG/PLUNGER POPPED OUT OF ANGIOCATH. BLOOD AND CONTRAST RELEASED ONTO PT GOWN. CUSTOMER RESPONSE ON 05-JAN-2025. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY? 23-12-2025. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. THE MALFUNCTION OCCURRED DURING CT CONTRAST INFUSION, EXPOSURE TO BLOOD AND BODILY FLUIDS, CONTRAST. THE RATE USED (5.5ML/SEC) IS APPROPRIATE FOR A PE STUDY USING OMNIPAQUE 300 AND A 20G SINGLE PORT NEXIVA CATHETER (POSTER ATTACHED). A SPIKE IN PRESSURE IS NOTED ON THE GRAPH IN THE SUMMARY. IT DOES NOT APPEAR THAT THE INJECTION WAS ABORTED SO THIS COULD BE DUE TO A CHANGE IN ARM POSITION. THERE IS SOME DOCUMENTATION ABOUT PATIENT COOPERATION SO I AM WAITING TO SPEAK TO THE PRIMARY TECHNOLOGIST TO GET MORE INFORMATION. IF I GATHER ANY MORE INFORMATION THAT WOULD BE BENEFICIAL TO THE TEAM, I WILL BE SURE TO SHARE.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143201 NEXIVA MAXZERO PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5120883 00382903835560

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown