BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA MAXZERO

    MDR report key: 25028587 · Received April 29, 2026

    Report

    Report Number
    1710034-2026-00482
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    April 17, 2026
    Report Date
    April 29, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835560
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    G.4. K183399; K243403 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 OF A LEAK COULD NOT BE VERIFIED FROM THE SCREENSHOT THAT WAS PROVIDED FOR INVESTIGATION. THE IMAGE ON THE SCREENSHOT SHOWED A 20G NEXIVA IV CATHETER WITHOUT THE NEEDLE. THE CATHETER ADAPTER AND SEPTUM WERE CIRCLED. A NOTE THAT ACCOMPANIED THE IMAGE INDICATED THAT BLOOD WAS LEAKING FROM THE CIRCLED HUB. NO BLOOD OR LEAKS COULD BE CONFIRMED FROM THE IMAGE. THERE WERE NO OTHER SIMILAR COMPLAINTS FROM THE IMPLICATED LOT. ALTHOUGH THE IMAGE AND MANUFACTURING RECORDS DO NOT SUPPORT THE COMPLAINANT¿S DESCRIPTION OF THE REPORTED EVENT, 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. 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

    IT WAS REPORTED THAT NEXIVA LEAKED AT THE SEPTUM. 3 DIFFERENT IVS FROM 2 DIFFERENT BOXES, BLOOD LEAKING FROM CIRCLED HUB TODAY WHEN PLACED IN PATIENT. BLOOD LEAKING FROM SEPTUM / BLOOD EXPOSURE ADDITIONAL INFORMATION: IT WAS DIFFERENT PATIENTS. TO CLARIFY, THIS WAS A MALFUNCTION OF THE IV CATHETER NOT A BLOOD EXPOSURE FOR STAFF IT IS STATED THAT 'BLOOD EXPOSURE OCCURRED' WAS THE USER WEARING PPE (GLOVES)? YES WAS THERE ANY EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS? NO WAS THERE ANY HARM/INJURY RELATED TO THE REPORTED EXPOSURE? NO.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207595 NEXIVA MAXZERO PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6063721 00382903835560

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown