Events

Recall of BD Q-SYTE

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
    38430
  • Event Risk Class
    II
  • Event Initiated Date
    2015-02-18
  • 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
    May fail to conform to a claim made by the manufacturer or importer relating to its performance and may be hazardous to health: the silicone column of the septum of the bd q-syte luer access split septum device is torn resulting in leakage of blood or infusate from the side holes or the remote potential for air bubbles to enter into the bloodstream if a negative pressure/vacuum situation is created. date the event was first identified: december 24 2014. description of how the event was identified: an increase in the number of complaints for this product was identified internally. note that there have been no complaints for air in the line related to the use of the device with a peripheral iv or a cvc line. there have also been no complaints for this product from canadian customers.

Device

BD Q-SYTE
  • Model / Serial
    Model Catalog: 385100 (Lot serial: 4128926)
  • Product Description
    BD Q-SYTE LUER ACCESS SPLIT SEPTUM
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.