MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® BLAKEMORE ESOPHAGEAL-NASOGASTRIC TUBE; BLAKEMORE TUBE

Model Number 0092100

Device Problem Difficult to Remove (1528)

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

Event Date 12/05/2022

Event Type  malfunction  

Event Description

It was reported that the user could not remove plugs from blakemore tube.This delayed the patient care.The device was unfit for use after clinicians used instruments to try to remove the plugs and ended up damaging the tube.As per additional information received via mail on 15-dec-2022, stated that the patient was not injured but the care requiring the blakemore tube was delayed.It took several people to try and remove the plugs and they had to resort in opening another blakemore tube thinking it was defective.It was critical situation that the patient was bleeding profusely and the delay caused unnecessary bleeding that could have been stopped if the blakemore tube was in place.

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 could not remove plugs from blakemore tube.This delayed the patient care.The device was unfit for use after clinicians used instruments to try to remove the plugs and ended up damaging the tube.As per additional information received via mail on 15-dec-2022, stated that the patient was not injured but the care requiring the blakemore tube was delayed.It took several people to try and remove the plugs and they had to resort in opening another blakemore tube thinking it was defective.It was critical situation that the patient was bleeding profusely and the delay caused unnecessary bleeding that could have been stopped if the blakemore tube was in place.

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.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: test balloons for air leaks and coat the lower parts of the tube and both balloons with a thin coat of lubricating jelly.Evacuate all the air from the gastric and esophageal balloons and reinsert the rubber plugs.After spraying the nostrils with a topical anesthetic, pass the tube through the nostril until the tip is in the posterior pharynx or throat.As the patient swallows water, pass the tube to at least the 50cm mark so that the tube numbers marked on the tubing will be along the right lateral aspect of the esophagus.Proper placement may be verified by x-ray.Inflate the gastric balloon with 200cc to 250cc of air, clamp conical portion of the gastric balloon inflation tube approximately 3cm from the end (avoid the small tubular portion of the gastric balloon), and pull back on the tube until resistance is encountered.(the gastric balloon is so constructed that with the numbers on the tube in the right lateral position, the cardia and fundus of the stomach will be engaged.) after the gastric balloon has been engaged, 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 held in place by an adhesive tape band.Finally, inflate the esophageal balloon to 35-40mm of mercury pressure.Next, aspirate through the stomach tube all air, water and blood.It is necessary during this step to irrigate the tube and stomach continuously with 50cc of water to prevent clotted blood from plugging the tube.Caution: it is most important that the stomach be cleared of blood promptly since subsequent sampling will be a true index of the effectiveness of hemorrhage control from the varices in the esophageal wall.If, after careful lavaging of the stomach for 30 minutes bright red bleeding continues, increase the esophageal balloon pressure to 45mm of pressure.At the same time, continue to wash the stomach with water so that the moment bleeding is controlled, it will be detected.Under normal circumstances esophageal balloon pressure should not exceed 45mm of mercury, and it is not uncommon for a patient to complain of substernal pressure as the higher pressures in the balloon are reached, particularly if they are reached too rapidly.When the balloon is in the proper position, the pressure will vary with respiratory movements and esophageal contractions.Occasionally these variations will cause the balloon pressure to rise to 70mm of mercury.The base line pressure is the one of importance, and not the transient peak pressures.If esophageal balloon pressure is maintained at 45mm of mercury and bleeding continues, it is suggestive of a gastric wall varix.In this case, the patient is given additional sedation if necessary and the tube is snugged up on the nose firmly and taped securely.Finally, the gastric balloon is inflated with more air gradually up to a total of 300-400cc of air.Warning: this degree of pressure causes ulceration of the mucosa within a few hours; therefore, patient must be prepared for suture of the gastric varices as soon as the general condition permits.After the minimal pressure in the esophageal balloon has been determined by evidence of control of bleeding, clamp the tubing as indicated in the diagram to prevent air leaks.Despite this precaution, frequent pressure checks should be made (every 30-60 minutes) to guard against any undetected air leaks in the system.After the stomach has been completely evacuated of blood, connect the stomach aspiration tube to constant suction during the first 12 hours only.Irrigate and aspirate the tube every 30 minutes with 50cc of warm water, and record color of aspirated fluid.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.

• Brand Name: BARD® BLAKEMORE ESOPHAGEAL-NASOGASTRIC TUBE
• Type of Device: BLAKEMORE 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: 16033673
• MDR Text Key: 308386133
• Report Number: 1018233-2022-09768
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00801741076800
• UDI-Public: (01)00801741076800
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0092100
• Device Catalogue Number: 0092100
• Device Lot Number: MCGN3698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2022
• 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