Dive Brief:
- BD has recalled tubes used to manage bleeding after receiving reports of two serious injuries and one death linked to the devices.
- The Class I recall, which the Food and Drug Administration publicized Friday, involves updating the instructions for use. BD is keeping the devices on the market.
- The updated instructions address difficulties users sometimes face when preparing the devices. The challenges can delay diagnosis or treatment and cause or prolong low blood pressure.
Dive Insight:
The recall affects five models of BD’s esophagogastric balloon tamponade tubes. Healthcare professionals use the flexible tubes to find and control bleeding from enlarged veins in the esophagus and stomach in critical and emergency situations. Pressure from balloons compresses parts of the body to control bleeding and suction ports allow the removal of fluids from the esophagus and stomach.
BD has learned that users are sometimes unable, or find it difficult, to remove plastic plugs from the rubber lumen, the cavity that runs through the tube. Users need to remove the plugs to inflate the balloons. In some cases, the struggle to remove a plug damages the tube and makes the device unusable.
“Potential health consequences include delay in diagnosis or delay in treatment which may result in the onset or prolongation of hypotension and its potential short and long-term complications, up to and including death,” the FDA said in the notice. “This issue may also result in additional and unexpected diagnostic and medical/surgical interventions to manage the patient’s bleeding.”
BD has updated its instructions for use to mitigate the risk. The company sent recommended actions to customers on April 17 and followed up with more detailed instructions on May 19. The FDA posted a Class I recall entry in its database on May 20.
The updated instructions advise users to remove plugs before use with patients. BD is recommending healthcare professionals insert one jaw of a hemostat, a type of forceps used to control bleeding during surgery, between the plug and the tube. After rotating the jaw around the plug’s circumference, users should remove the hemostat followed by the plug. BD is advising users to store a hemostat with tubes.
BD’s C.R. Bard subsidiary is overseeing the recall. Bard began Class I recalls of cardiovascular devices in February and March. The FDA published early alerts about the atherectomy catheter and intravascular catheter recalls.
