Smiths Medical Identifies Issue with Bivona Tracheostomy Tubes

Smiths Medical, now a part of ICU Medical, recently announced potential issues with certain Bivona Tracheostomy Tubes after initially sending out an urgent field safety notice on May 29 detailing that the company had identified that the securement flange of specific lots of the products may tear because of a manufacturing defect.

If the flange is torn or broken, the tracheostomy tube may not stay in position in the trachea, leading to tracheostomy displacement or decannulation. This could result in an inability to properly ventilate or protect the airway. Currently, the company has received 35 reports of serious injury, and one death connected to the issue.

Smiths is recommending customers to follow all instructions, including warning and cautions contained in the instructions for use with “heightened awareness.” If affected product is found in inventory, the company said to discard it. Replacement products or credits will be distributed to affected customers if they contact a company representative with a certificate of destruction.

FDA has been notified of the action.

“Smiths Medical is committed to patient safety and is focused on providing exceptional product reliability and the highest level of customer satisfaction,” Andy Mathein, vice president of quality at Smiths, wrote in the field safety notice.