BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA

    MDR report key: 19250382 · Received May 6, 2024

    Report

    Report Number
    1710034-2024-00396
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    April 3, 2024
    Report Date
    June 14, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835584
    PMA / PMN Number
    K231239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT THAT THE EXTENSION TUBE WAS BALLOONED AND EXPANDED WAS CONFIRMED FROM THE PHOTOGRAPHIC EVIDENCE THAT WAS PROVIDED FOR INVESTIGATION. ONE PHOTO SHOWED THE NEXIVA DEVICE IN USE. THE EXTENSION TUBING WAS BALLOONED. 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.

    Additional Manufacturer Narrative · 0

    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

    IT WAS REPORTED THAT BD NEXIVA TUBING BALLOONED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEXIVA 1.75" EXPERIENCED ISSUES DURING POWER INJECTION/CT, THEN AFTER PULLING UP THE DRESSING THEY FOUND THAT THE TUBING WAS DAMAGED/EXPANDED. REMOVED FROM PATIENT, NO PATIENT INJURY TO MY KNOWLEDGE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522302 BD NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 00382903835584

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown