Events

Recall of BD NEXIVA CLOSED IV CATHETER SYSTEM - SINGLE PORT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECTON DICKINSON CANADA INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    92404
  • Event Risk Class
    III
  • Event Initiated Date
    2014-04-03
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Leaking septa have been observed in manufacturing and also in customer complaints. health canada requested on december 16 2013 that "all users of the product" be notified of the situation an "informal notification" a "level ill recall". date problem was firstidentified: april 30 2012 how the problem was identified: during routine in-process leak inspection of product during manufacture. customer complaints: observed increased complaint rate for leakage during april-june 2012.

Device

BD NEXIVA CLOSED IV CATHETER SYSTEM - SINGLE PORT
  • Model / Serial
    Model Catalog: 383512 (Lot serial: >10 numbers contact mfg); Model Catalog: 383516 (Lot serial: >10 numbers contact mfg); Model Catalog: 383517 (Lot serial: >10 numbers contact mfg); Model Catalog: 383519 (Lot serial: >10 numbers contact mfg); Model Catalog: 383532 (Lot serial: >10 numbers contact mfg); Model Catalog: 383536 (Lot serial: >10 numbers contact mfg); Model Catalog: 383537 (Lot serial: >10 numbers contact mfg); Model Catalog: 383539 (Lot serial: >10 numbers contact mfg); Model Catalog: 383540 (Lot serial: >10 numbers contact mfg); Model Catalog: 383591 (Lot serial: >10 numbers contact mfg); Model Catalog: 383594 (Lot serial: >10 numbers contact mfg)
  • Product Description
    BD Nexiva Closed IV Catheter System - Single Port
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.