BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA

    MDR report key: 24942345 · Received April 21, 2026

    Report

    Report Number
    1710034-2026-00439
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    April 9, 2026
    Report Date
    April 14, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G.4. K183399; K243403.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ADAPTER AND TUBING SEPARATED. THE CATHETER HUB AND EXTENSION TUBE WAS DISLOCATED. IT WAS UNKNOWN WHETHER THE LEAK OCCURRED DUE TO THE DETACHMENT. (B)(6) 2026 CLARIFICATION RECEIVED: THE EVENT WAS A DISLOCATION OF THE CATHETER HUB AND EXTENSION TUBE. IT IS UNKNOWN WHETHER THE LEAK OCCURRED DUE TO THE DETACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113548 NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1