Bleeding Tube Recall Issued by BD Following Patient Death: FDA

Manufacturer is updating device instructions due to difficulties removing certain device parts, which may delay potential treatments.

Federal health officials have announced a Class I recall of certain Becton, Dickinson and Company (BD) tubes used to stop bleeding, following reports of patient injuries and death.

The U.S. Food and Drug Administration (FDA) announced the esophagogastric balloon tamponade tube recall on May 23, following reports of two serious injuries and one death linked to difficulties removing plastic plugs from the device’s opening, an essential step needed to access the channel used to inflate the balloon.

The BD esophagogastric balloon tamponade tubes are flexible tubes used in critical and emergency situations to control bleeding from enlarged veins in the esophagus and stomach. The tubes work by inflating balloons that apply pressure to the bleeding site, while suction ports remove blood and other fluids from the esophagus and stomach.

However, the manufacturer has learned that users and other medical personnel may have difficulty removing plastic plugs from the rubber opening of certain tubes. In some cases, the device may even be damaged during removal and require a replacement.

These difficulties may lead to delays in diagnosis or treatment, which could lead to the worsening of symptoms, as well as additional complications, including death. Additional diagnostic procedures, medical care or surgical interventions may also be needed to manage the bleeding effectively.

The FDA has given this recall a Class I designation, indicating it is the most serious of its kind, and that problems caused by the product pose a high probability of severe or life threatening injuries.

Healthcare providers are urged to check all inventory for the following recalled products and associated Unique Device Identifiers (UDIs):

• Bard Minnesota Four Lumen Esophagogastric Tamponade Tube (UDI: 0092220)
• Bard Blakemore Esophageal Nasogastric Tube (UDI: 0092100)
• Bard Blakemore Esophageal Nasogastric Tube (Child) (UDI: 0092110)
• Bard Blakemore Esophageal Nasogastric Tube (Intermediate) (UDI: 0092300)
• Bard Single Intragastric Linton Balloon Tube (UDI: 0092740)

Becton, Dickinson and Company began notifying affected customers with an initial letter sent on April 17, followed by a second notice with more detailed instructions on May 19.

According to the recall instructions, healthcare providers should:

• Remove the plastic plugs from the device before use and keep them with the product
• Use a hemostat to assist with removal by inserting its jaws around the plug, rotating, and then pulling the plug out
• Check the balloons for air leaks after plug removal and before use
• Ensure that backup balloon tamponade tubes are available in case of damage during preparation

Facilities should post the recall notice at all storage locations and distribute it to anyone who uses or handles the affected devices, including any locations where the product was transferred.

Customers with questions can contact BD at productcomplaints@bd.com or call 1-844-823-5433 and say “product complaint.”