FDA: Enteral Access Systems for Certain Feeding Tubes Associated with Pneumothorax Events
January 17, 2018 | Risk Management News
Feeding tube placement procedures using Corpak Medsystems' Cortrak 2 Enteral Access System are associated with pneumothorax events, the U.S. Food and Drug Administration (FDA) said in a January 12, 2018, letter to healthcare providers. FDA received 51 Medical Device Reports about pneumothorax events related to these devices from January 2012 to July 2017, 11 of which featured a report of patient death. Pneumothorax is a rare complication in which air leaks into the space between the lungs and chest wall. It is associated with “blind insertion" of feeding tubes.