MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® MINNESOTA FOUR LUMEN TUBE

Model Number 0092220

Device Problem Difficult to Remove (1528)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/22/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the user had a complaint regarding the minnesota tube which was used for upper gastrointestinal bleeding or esophageal bleeding and there had been several incidents with this product.According to the users, during the installation of the probe, it was impossible to remove 2 of the 4 white plugs that were present at the ports of the esophageal balloon and the gastric balloon.During the last installation, they had to request a probe on another unit, which led to delay in the installation of the probe while the user was hemorrhaging with a precarious clinical situation.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿incorrect plug/funnel dimension design".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "caution: this product contains natural rubber latex which may cause allergic reactions.Caution: test balloons for air leaks and proper inflation before using tube.Caution, consult accompanying documents recommended apparatus 1.Four lumen minnesota esophagogastric tamponade tube with nasal guard.2.18 fr.Levin tube 3.12 or 14 fr.Aspirating catheter.4.Mercury manometer or aneroid gauge type sphygmomanometer.5.Topical anesthetic.6.Water soluble lubricating jelly.7.Glass of water with straw.8.Rubber tubing for manometric connections.9.Rubber shod clamps.10.0.85% sodium chloride solution in ice.11.Suction machine (120-200mm hg.).12.Suction machine (60-120mm hg.).Instructions for use 1.Testing the balloons: each balloon must be inflated with air and examined for air leaks before intubation.With the manometer connected to the pressure monitoring outlet, the pressure within the gastric balloon is determined following distension of the balloon with 100, 200, 300, 400 and 500 ml of air.The balloons are then deflated and coated with a water soluble lubricating jelly.2.Preparing the patient for intubation: the patient is placed on the fluoroscope table with his head elevated approximately 45°.The posterior pharynx and nostrils are anesthetized with a topical anesthetic.The 18 fr.Levin tube is then lubricated with water soluble lubricating jelly and passed into the patient¿s stomach.Prior to use it needs to be verified that the balloon is inserted correctly into the patient¿s stomach.The stomach is thoroughly lavaged with 0.85% sodium chloride solution in ice to remove blood clots.Complete removal of blood from the stomach reduces the risk of aspiration of blood into the trachea during intubation.Following gastric lavage, the levin tube is withdrawn.3.Passage of four lumen esophagogastric tamponade tube: after suctioning the air from the gastric and esophageal balloons, rubber shod clamps are clamped on the two pressure monitoring outlets and plastic plugs are inserted into the lumens for inflation of the esophageal and gastric balloons.This maneuver maintains deflation of the balloons during intubation.The tube and deflated balloons are introduced through one of the nostrils into the posterior pharynx.With assistance of the patient having a few sips of water through a straw, the tube is inserted to the 50cm mark indicating that the tip of the tube is in the stomach.The position of the tube should be confirmed by fluoroscopic visualization showing the tip well below the diaphragm.Other established clinical uses for verification are acceptable.Follow institutional procedures.Suction is applied immediately to the gastric and esophageal aspiration lumens to avoid regurgitation of gastric juice, blood and saliva during inflation of the gastric balloon.Aspiration of gastric juice from the gastric aspiration lumen provides further evidence for the proper location of the tube.4.Positioning four lumen esophagogastric tamponade tube: the rubber shod clamp and plastic plug are removed from the pressure monitoring outlet of the gastric balloon and the gastric balloon inflation lumen.The pressure monitoring outlet for the gastric balloon lumen is connected to the mercury manometer.Increments of 100 ml of air are introduced through the gastric balloon inflation lumen until a total of 450-500 ml of air fill the gastric balloon.As the air is introduced into the gastric balloon, the intragastric balloon pressure is monitored.Warning: if the intragastric balloon pressure recorded following intubation is 1.5cm hg greater than the intragastric balloon pressure at an identical volume noted prior to intubation, the gastric balloon is located within the esophagus and further distention of the balloon may result in over distention and rupture of the esophagus.If an elevated intragastric balloon pressure is recognized, the balloon must immediately be deflated and reintroduced into the stomach.When the gastric balloon lying in the stomach has been inflated with 450-500 ml of air, the air inlet and pressure monitoring outlet of the gastric balloon are ligated doubly with sutures or are clamped with a traumatic clamps or clips.The tube is pulled back gently until the resistance of the diaphragm is firmly felt against the gastroesophageal junction.With a minimum of tension on the tube, fix the upper end of the tube as it emerges from the nostril by a cuff of sponge rubber.The nasal guard is secured to the tube by adhesive tape passed around its mid-portion and spiraled around the distal end of the tube.Lavage of the stomach with 0.85% sodium chloride solution in ice should be accomplished through the gastric aspiration lumen until the aspirate is clear.If blood is detected continually in the gastric aspirate, the esophageal balloon should be inflated to a pressure of 3.5 to 4.5cmhg as recorded continuously by manometer attached to the esophageal balloon monitoring outlet.If bleeding continues during esophageal tamponade, it usually originates from a gastric varix.In this case, external traction upon the tube should be initiated.The tube is kept taut by fixing it to the nasal guard at the point where the tube emerges from the nostril.Warning: external traction upon the tube causes ulceration of the mucosa within a few hours; therefore, external traction must be employed cautiously for short time intervals.Follow institutional guidelines.The gastric aspiration lumen is connected to intermittent 60-120mmhg suction.Continuous aspiration of the esophagus to remove swallowed saliva and regurgitated blood is accomplished by 120-200mmhg suction.5.Performance of esophagogastric tamponade: the esophageal balloon pressure should be maintained at the lowest level that will stop bleeding.Warning: the esophageal balloon pressure should not exceed 4.5cmhg.After bleeding has been terminated by tamponade, the pressure in the balloon is reduced 0.5cmhg every 3 hours until an intraesophageal balloon pressure of 2.5cmhg is achieved without bleeding.Warning: since continual pressure of 2.5-3.0cmhg on the esophagus for long time intervals may induce esophageal necrosis, periodic deflation of the esophageal balloon is undertaken for 5 minutes every 6 hours.If an intraesophageal balloon pressure of 2.5cmhg can be maintained without bleeding, esophageal tamponage at this pressure is maintained for at least 12 hours.After this time interval, the balloon is deflated and left in place for another 4 hours.6.Extubation: if bleeding does not reoccur, the four lumen esophagogastric tamponade tube is gently withdrawn.To assure deflation of the balloons, transect the protruding end of the tube before removing it.After extubation, the mouth and posterior pharynx are suctioned with the plastic or rubber aspirating catheter to remove regurgitated secretions.Warning: do not use lubricants containing mineral oil or petrolatum as they are harmful to rubber.Storage: store tube at room temperature away from direct exposure to light, preferably in the original packaging.Sterilization: if desired, the tube may be sterilized by ethylene oxide or steam autoclave.Exposure times will vary depending on the type of equipment used.The equipment manufacturer¿s recommendations should be followed along with the proper use of biological controls.Warning: remove plastic plugs prior to sterilization.Reuse precaution: this is a single use device.Do not re-sterilize a portion of this device after initial sterilization and/or use.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failures, and/or lead to injury, illness or death of the patient." h11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.

Event Description

It was reported that the patient used the minnesota tube for upper gastrointestinal bleeding or esophageal bleeding and there had been several incidents with this product.According to the users, during the installation of the probe, it was impossible to remove 2 of the 4 white plugs that were present at the ports of the esophageal balloon and the gastric balloon.During the last installation, they had to request a probe on another unit, which led to delay in the installation of the probe while the user was hemorrhaging with a precarious clinical situation.

Manufacturer Narrative

The reported event is confirmed, cause unknown.A minnesota tube was returned with 3 plugs.2 plugs were inserted into the stomach balloon funnels and the third was inserted into the lower esophagus ball funnel.2 plugs were easily removed, but the top stomach balloon plug took considerable effort to remove.As it is unknown when the plug was damaged and pushed into the funnel, as the reported event did state the patient struggled to remove it.The reported event will be confirmed cause unknown.Although a specific root cause cannot be determined, based on the risk document a potential root cause for this event could be, "-incorrect plug/funnel design".The device was used for treatment purposes.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "passage of four lumen esophagogastric tamponade tube: after suctioning the air from the gastric and esophageal balloons, rubber shod clamps are clamped on the two pressure monitoring outlets and plastic plugs are inserted into the lumens for inflation of the esophageal and gastric balloons.This maneuver maintains deflation of the balloons during intubation." "positioning four lumen esophagogastric tamponade tube: the rubber shod clamp and plastic plug are removed from the pressure monitoring outlet of the gastric balloon and the gastric balloon inflation lumen." "sterilization: if desired, the tube may be sterilized by ethylene oxide or steam autoclave.Exposure times will vary depending on the type of equipment used.The equipment manufacturer¿s recommendations should be followed along with the proper use of biological controls.Warning: remove plastic plugs prior to sterilization." h11: section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.H3 other text : the actual/suspected device was evaluated.

Event Description

It was reported that the patient used the minnesota tube for upper gastrointestinal bleeding or esophageal bleeding and there had been several incidents with this product.According to the users, during the installation of the probe, it was impossible to remove 2 of the 4 white plugs that were present at the ports of the esophageal balloon and the gastric balloon.During the last installation, they had to request a probe on another unit, which led to delay in the installation of the probe while the user was hemorrhaging with a precarious clinical situation.

• Brand Name: BARD® MINNESOTA FOUR LUMEN TUBE
• Type of Device: MINNESOTA FOUR LUMEN TUBE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15177074
• MDR Text Key: 297358113
• Report Number: 1018233-2022-06110
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00801741076824
• UDI-Public: (01)00801741076824
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: 0092220
• Device Catalogue Number: 0092220
• Device Lot Number: MCFT1956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2022
• Initial Date FDA Received: 08/05/2022
• Supplement Dates Manufacturer Received: 10/26/2022; 02/01/2023
• Supplement Dates FDA Received: 10/31/2022; 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other