BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA

    MDR report key: 24075066 · Received January 14, 2026

    Report

    Report Number
    1710034-2026-00015
    Event Type
    Malfunction
    Date Received
    January 14, 2026
    Date of Event
    December 19, 2025
    Report Date
    February 11, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835393
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT OF DAMAGED EXTENSION TUBING WAS CONFIRMED; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. ONE 18G NEXIVA IV CATHETER WAS RETURNED FOR INVESTIGATION WITH EVIDENCE OF USE. A PORTION OF THE IV CATHETER WAS COVERED IN THE DRESSING THAT WAS USED TO SECURE IT. THE EXPOSED SECTION OF THE EXTENSION TUBING EXHIBITED EVIDENCE THAT IT HAD BALLOONED OR EXPANDED FROM ITS ORIGINAL SHAPE. A FUNCTIONAL TEST REVEALED NO LEAKS OR OCCLUSIONS IN ANY PART OF THE IV CATHETER. THE DAMAGE LIKELY OCCURRED DURING USE; HOWEVER, THE ROOT CAUSE COULD NOT BE VERIFIED. THIS TYPE OF DAMAGE CAN OCCUR IF THE CATHETER IS KINKED, OBSTRUCTED, OR PRESSURIZED BEYOND THE PRESSURE LIMIT. THE INSTRUCTIONS FOR USE (IFU) INDICATE TO AVOID KINKING OR OBSTRUCTING CATHETER DURING POWER INJECTION. IN THE EVENT OF AN OCCLUSION, POWER INJECTOR PRESSURE-LIMITING FEATURES MAY NOT PREVENT CATHETER FAILURE. THE IFU ALSO INDICATES THAT 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. 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.

    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 NEW INFORMATION.

    Description of Event or Problem · 0

    COMPLAINT DESCRIPTION: HOLE IN LATERAL LINE NEXIVA NEEDLE. HAS THIS PRODUCT ALREADY BEEN USED IN PATIENTS: YES. HAS THERE BEEN A RISK TO THE PATIENT OR USER: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137076 NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5211924 00382903835393

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown