Teleflex Medical Incorporated has issued an urgent medical device recall for certain Hudson RCI Sheridan endotracheal tubes and connectors distributed from October 2016 to May 2019. The devices are used for oral or nasal intubation for airway management. Teleflex has reported that the connector could disconnect from the endotracheal tube, resulting in insufficient oxygenation to the patient.
Reported Incidents of Injury & Death
According to Teleflex’s recall letter, there were 192 reported incidents involving the ET tube and connectors, with two reported deaths and one injury related to the ET tube disconnection. The Federal Drug Administration (FDA) cited four reports of death and additional reports of serious injury where an ET tube disconnection may have been a factor. The FDA has classified this a Class I recall (“a situation in which there is a reasonable probability that use of, or exposure to, a violative product will cause serious adverse health consequences or death”).
In one report from the FDA MAUDE Adverse Event database, a health facility described an incident where the Hudson ET tube connector came apart three times in the same patient, requiring reintubation. The health facility also noted other reports of the same issue occurring across its entire organization, with additional reports of cuff failure and cuff tearing. The health facility has since pulled the product from its shelves. In the report to the FDA, the health facility stated that the information it received from the company representative was that Teleflex started having issues in 2016 and changed its manufacturer due to an issue with the plastic.
In a follow-up report from the FDA MAUDE Adverse Event database for this same patient, the facility noted that “‘the et tube connector continuously became dislodged and the patient began to desaturate. It was reported the patient had a do not resuscitate order and, therefore, was not re-intubated. It was reported the patient expired.”
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If you or a family member was injured or died as a result of an endotracheal tube disconnection or other failure, contact at Vaage Law. Our defective medical product attorneys are currently reviewing and accepting cases throughout San Diego. Call (619) 338-0505 to get started.