Health Canada — Medical Devices · Canada · 2015-05-08 · Type II
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Reported risk: Smiths Medical has become aware of the potential for compression of the inner cannula as a result of handling or certain cleaning methods used, outside of the methods described in the IFU. Compression can result in a shorter overall length and may lead to a build-up of secretions within the end of the tracheostomy tube with risk of infection or occlusion. Smiths medical is therefore advising customers of additional information for safe and effective use of Bivona inner cannula.
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