The FDA issued a notice highlighting a letter issued by BD and its C.R. Bard Urology and Critical Care subsidiary warning of new balloon device instructions.
This warning follows one death associated with the device issue.
BD sent affected customers a notice updating instructions for all lots of certain esophagogastric balloon tamponade tubes. Such devices, made of flexible tubing, help identify and control bleeding from enlarged veins in the esophagus and stomach in emergency situations. The tubes use pressure from balloons to compress an area and help control the bleeding. Its suction ports remove fluids from the esophagus and stomach.
According to the FDA, BD learned that users are sometimes unable or find it difficult to remove the plastic plugs from the rubber lumen in order to inflate the gastric and/or esophageal balloons. In some cases, the devices may become damaged during plug removal. These cases require a replacement device.
Potential health consequences include delay in diagnosis or treatment. That can lead to the onset or prolongation of hypotension and its potential short and long-term complications, which include death. The issue may also lead to additional and unexpected diagnostic and medical/surgical interventions to manage bleeding.
BD reported two serious injuries and one death associated with the issue.
The company sent all affected customers a letter with recommend actions on April 17. On May 19, it sent a follow-up letter iwth mroe detailed instructions. Customers should prepare the device before use by removing the plugs and setting them aside. They should also fully open the 5″ straight smooth jaw hemostats and insert one hemostat jaw between the plug and rubber lumen. With the jaw inserted, they should rotate the jaw around the plug’s circumference. Following the removal of plastic plugs, users should test balloons for evidence of air leaks.
