FDA issues Class I alert on emergency use esophagogastric tubes
The U.S. Food and Drug Administration (FDA) said it is aware that C.R. Bard Urology and Critical Care, a subsidiary of multinational medical device manufacturer BD, has alerted customers to an urgent update to use instructions on a line of esophagogastric balloon tamponade tubes, which are used to control bleeding in the esophagus and stomach.
In a letter sent to customers, BD and its subsidiary acknowledged some clinicians are having difficulty removing the plastic plugs, which are necessary to be dislodged in order for the balloons to inflate. The balloon itself is necessary to apply pressure to veins in order to prevent excessive blood loss.
Due to a defect, struggling to remove the plugs can damage the devices, rendering them inoperable. Given that the balloon tubes are used in emergency situations—and that a delay in administering care could result in the death of a patient—the urgent updated use instructions have been designated as Class I by the FDA, reserved for the most serious notices and recalls.
What products are impacted?
Here is a complete list of devices that could be damaged if new use instructions are not followed:
- Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, Model 0092220.
- Bard Blakemore Esophageal Nasogastric Tube, Model 0092100
- Bard Blakemore Esophageal Nasogastric Tube (Child), Model 0092110
- Bard Blakemore Esophageal Nasogastric Tube (Intermediate), Model 0092300
- Bard Single Intragastric Linton Balloon Tube, Model 0092740
The Unique Device Identifiers (UDI numbers) associated with the defective products are 00801741076824, 00801741076800, 00801741076817, 00801741076831 and 00801741076848.
Next Steps
The FDA said it’s currently reviewing information about this potentially high-risk device issue and will keep the public informed of any developments. For now, there is no recall, and users are advised to follow updated instructions, which can be found in the letters BD sent to known customers in possession of affected devices.
Mainly, the update is focused on how to safely remove the plug from the tubes, with BD instructing users to do the following:
- Before use with patients, prepare the device by removing the plastic plugs and set them aside to remain with the device.
- To aid in plug removal, fully open the 5” Straight Smooth Jaw Hemostats and insert one hemostat jaw between the plug and the rubber lumen.
- While the hemostat jaw is inserted, rotate the jaw around the plug’s circumference as seen in the image below. Remove the hemostat, then the plug.
- Following removal of the plastic plugs, test the balloons for evidence of air leaks prior to proceeding with the remaining steps required for placement as described in the original instructions for use.
BD also recommended that the hemostat tool be stored with the balloon tamponade tubes to facilitate safe removal of the plastic plugs. In addition, they recommend storing extra backup devices wherever they’re used, in case one breaks as a result of a stubborn plug.
Both the company and the FDA are asking that the product alert be shared. It's available here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.