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