BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA

    MDR report key: 25200880 · Received May 18, 2026

    Report

    Report Number
    1710034-2026-00528
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 27, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835324
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED PACKAGE DAMAGE WITH STERILITY BREECH. MANY BD NEXIVA PACKAGES BEING OPENED AND LOSING THEIR STERILITY. SOME PACKAGES REMAINED INTACT; HOWEVER, THE SHAPE OF THE IV CATHETER PACKAGING WAS ALREADY COMPROMISED. THE HOSPITAL IS RELUCTANT TO USE THE PRODUCTS DUE TO CONCERNS REGARDING PRODUCT SAFETY AND QUALITY THE PLASTIC PART OF THE PACKAGING APPEARED SHRIVELED, AS IF EXPOSED TO EXTREME HEAT, RESULTING IN MANY BD NEXIVA PACKAGES BEING OPENED AND LOSING THEIR STERILITY. SOME PACKAGES REMAINED INTACT; HOWEVER, THE SHAPE OF THE IV CATHETER PACKAGING WAS ALREADY COMPROMISED. THE HOSPITAL IS RELUCTANT TO USE THE PRODUCTS DUE TO CONCERNS REGARDING PRODUCT SAFETY AND QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392794 NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5274580 00382903835324

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown