BD Warns About Esophagogastric Balloon Tamponade Tubes After Death

The U.S. Food and Drug Administration (FDA) posted a notice of a letter issued by BD and its C.R. Bard Urology and Critical Care business, which warns of updated use instructions for all lots of certain esophagogastric balloon tamponade tubes.

BD sent the letter following reports of two serious injuries and one death related to the issue.

The devices are made of flexible tubing and used to identify and control bleeding from enlarged esophagus and stomach veins. The tubes use pressure from balloons to compress an area and control bleeding, and suction ports to remove fluids from the esophagus and stomach.

The company became aware that users are sometimes unable or find it difficult to remove the plastic plugs from the rubber lumen to inflate the balloons. The devices could become damaged when removing the plastic plugs, BD said, in which case a replacement device is necessary.

Health consequences from this issue include delayed diagnosis or treatment, potentially causing onset or prolongation of hypotension and its possible short and long-term complications. The issue can also cause additional, unexpected interventions to manage bleeding.

BD sent customers a letter with recommended actions on April 17 and a follow-up letter with more detailed instructions on May 19.

The company advised to remove plastic plugs and set them aside to remain with the device before use with patients. The five-inch Straight Smooth Jaw Hemostats should be fully opened and one hemostat jaw inserted between the plug and rubber lumen. While the hemostat jaw is in, the jaw should be rotated around the plug’s circumference.

After the plastic plugs are removed, the balloons should be tested for evidence of air leaks before proceeding with the remaining steps needed for placement described in the original Instructions for Use (IFU).