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

Catalog Number	0092220
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
Event or Problem Description
It was reported that the nasogastric tube was in place in patient and the gastric balloon lost air.When tube was pulled out, the gastric balloon appeared to have a large tear.
Event or Problem Description
It was reported that the esophageal tube was in place in patient and the gastric balloon lost air.When tube was pulled out, the gastric balloon appeared to have a large tear.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.Root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be ¿error of inspector".However, there was insufficient information to confirm this potential root cause.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: "caution: test balloons for air leaks and proper inflation before using tube.Instructions for use 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.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 percentage 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." udi format updated with available product information per gudid 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.

• Brand Name: BARD® MINNESOTA FOUR LUMEN TUBE
• Common Device Name: MINNESOTA 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: 19546902
• Report Number: 1018233-2024-03496
• Device Sequence Number: 6806109
• Product Code: KNT
• UDI-Device Identifier: 00801741076824
• UDI-Public: (01)00801741076824(11)220412(17)250228(10)MCGQ3687
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Catalogue Number: 0092220
• Device Lot Number: MCGQ3687
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male