Events

Safety Alert for Portex Bivona Inner Cannula for Bivona Adult Tracheostomy Tubes

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Smiths Medical.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-04-20
  • Event Date Posted
    2015-04-20
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150420.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: smiths medical portex bivona inner cannula for bivona adult tracheostomy tubes medical device manufacturer, smiths medical, has issued a medical device safety alert concerning its portex bivona inner cannula for bivona adult tracheostomy tubes [model/catalogue numbers: brc270, brc275, brc280, brc285, brc290, brca70, brca75, brca80, brca85, brca90; all lot numbers]. the manufacturer has become aware of the potential for compression of the inner cannula to occur as a result of handling or certain cleaning methods used with inner cannulae. compression can result in a shorter overall length. use of an inner cannula which is too short may lead to a build-up of secretions within the end of the tracheostomy tube which may cause infection or occlusion. the inner cannula should be handled and cleaned with care, and according to the instructions for use (“ifu”). according to the manufacturer, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 april 2015.

Device

Portex Bivona Inner Cannula for Bivona Adult Tracheostomy Tubes
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Smiths Medical Portex Bivona Inner Cannula for Bivona Adult Tracheostomy Tubes
  • Manufacturer
    Smiths Medical

Manufacturer

Smiths Medical