BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA

    MDR report key: 24134223 · Received January 21, 2026

    Report

    Report Number
    1710034-2026-00031
    Event Type
    Malfunction
    Date Received
    January 21, 2026
    Date of Event
    January 7, 2026
    Report Date
    March 4, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 DAMAGED EXTENSION TUBING WAS CONFIRMED; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. TWO PHOTOGRAPHS WERE PROVIDED FOR INVESTIGATION, WHICH SHOWED A 20G NEXIVA IV CATHETER 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. LIQUID WAS VISIBLE IN THE TUBING, BUT NO LEAKS WERE IDENTIFIED. THE DAMAGE LIKELY OCCURRED DURING USE; HOWEVER, THE ROOT CAUSE COULD NOT BE VERIFIED FROM THE PHOTOGRAPHS. 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.

    Description of Event or Problem · 0

    WE HAD A TUBING MALFUNCTION OR ¿LOOKS LIKE A COLLAPSE¿ IN THE TUBING DURING IMAGING PROCESS.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192278 NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown