MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® NASOGASTRIC SUMP TUBE WITH PREVENT® ANTI-REFLUX FILTER WITH ENFIT¿; NASOGASTRIC TUBE

Model Number EN0046160

Device Problem Nonstandard Device (1420)

Patient Problems Exposure to Body Fluids (1745); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/18/2023

Event Type  Injury  

Event Description

It was reported that there was a recent incident where one of their providers was using en0046160 for decompression.Unfortunately, they had an event in which one of these bard tubes was placed in a patient who was actively coding.They were unable to decompress the patient¿s stomach and ended up using scissors to cut the end of it off to connect suction.In doing so, the crisis nurse also had gastric contents sprayed all over them.They were aware that there were adapter options but stated they could not decompress through the small enfit hole.They would assume this tube would also have problems in other situations, such as bleeding or poisoning situations.This was a major patient safety event.If the product was unable to do what it was supposed to do, they had a problem.No medical intervention was reported.Per follow up via email on 24may2023, it was reported that the sample was discarded.They did not think the bard solution would meet the anesthesiologists¿ needed in an emergency.Also stated that this tube was needed during a code.Ultimately because the staff didn¿t have the adapters, they needed to cut off the fixed enfit adapter to utilize the suction feature.There was concern of the diameter of the enfit salem sumps for suctioning blood clots, food particles, pills, etc.

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.H3 other text : the device was not returned.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be "dimensions not designed correctly".It was 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 dhr review could not be performed without a lot number.The instructions for use were found adequate and state the following: "bard® nasogastric sump tubes instructions for use attention: all references to the ng tube, prevent® filter and lopez valve® hereafter are understood to be enfit¿ compatible.Read all instructions prior to use.Indications for use: bard® nasogastric sump tubes with enfit¿ connector are intended to be used for: ¿ decompression of stomach by suction or aspiration of gastric contents.¿ short-term administration of term tube feeding, lavage fluid and medications.Contraindications: ¿ patients with known tape or adhesive allergies.Warnings 1.Use with caution in patients with a history of head trauma, facial trauma, esophageal diseases and patients with potential for vomiting.2.Do not force nasogastric tube during insertions; damage to the nasal passage and mucosa and bleeding may occur.3.Measure insertion length carefully- excessive insertion length of tube into the stomach may lead to coiling and/or formation of tube-knot.4.Lubricate the tube generously with water soluble lubricant prior to insertion.Do not use petroleum-based products as they may be harmful to the respiratory tract.5.Reflux of gastric contents into the blue vent lumen indicates that the suction lumen is obstructed, or suction is too low.Routinely check for reflux in the blue vent lumen and clear as per applicable directions.Failure to clear the obstruction or clear prevent® filter may cause gas & fluid buildup in stomach, aspiration of gastric contents, aspiration pneumonia and other complications.6.Do not inject fluid through the prevent® filter as this may result in blockage and leakage of filter.7.Monitor patient for nasal erosion, sinusitis, esophagitis, esophagotracheal fistula, gastric erosion and pulmonary & oral infections.Statlock® nasogastric stabilization device: avoid contact with alcohol or acetone; both can weaken bonding of components and statlock® stabilization device pad adherence.Instructions for nasogastric tube insertion 1.Explain the procedure to the patient.2.Carefully measure to find desired length of the tube using the nasogastric tube as a measurement aid.To determine the insertion length: measure the tube from the tip of the nose to the earlobe and from the earlobe to the tip of the xiphoid process.Mark the length of the tube to be passed with a small piece of tape.3.Check the patient¿s nostrils for patency; select the nostril with best patency.4.Lubricate the full length of tube to be inserted.5.Insert the tube through the nose aiming down and back.When the tube hits the pharynx, if patient is able, have him or her flex his/her head forward and swallow.Advance the tube as the patient swallows.If resistance is met, rotating the tube may facilitate placement.6.Continue to advance the tube until the marked position on the tube is reached.Do not advance beyond the marked length as coiling and or knotting of the tube in the stomach may occur.7.Confirm tube placement per hospital policy.The tube has a radiopaque stripe facilitating x-ray confirmation.If proper placement of tube within the stomach cannot be confirmed, remove the tube gently and start the procedure again.8.Secure with a securement device or tape per hospital protocol.9.If applicable, ensure the lopez valve® with enfit¿ connector is snugly inserted into suction lumen to prevent suction loss.10.Keep blue vent lumen above the level of the patient¿s stomach to prevent reflux of stomach fluids into the blue lumen.11.Do not clamp air vent port while suction is being applied.Recommended suction settings always use lowest suction setting that will effectively decompress the stomach.For intermittent suction via thermotic pump, use ¿high¿ (gomco, 120mm hg).For intermittent suction via central source, set at ¿low¿ (30-40mm hg).For continuous suction, set at ¿low¿ (30-40mm hg).Increase slowly until flow is observed as necessary.Instructions for prevent® anti-reflux filter with enfit¿ connector 1.Firmly twist the white base of anti-reflux filter in blue air lumen vent of nasogastric tube.2.If gastric reflux in vent lumen is observed, clear the obstruction in the main lumen by following your hospital¿s standard protocol.Attach enfit¿ - compatible syringe to enfit¿ male fitting on anti-reflux filter and inject a minimum of 15cc of air to clear the blue air vent lumen of any gastric reflux.Do not inject fluid through filter.3.To cap nasogastric tube when tube is not connected to a suction source insert tethered cap that is attached to the barb in the suction lumen of nasogastric tube.Instructions for lopez valve® with enfit¿ connector (when included): 1.Attach medication port cap to side ¿c¿.2.Turn valve to position one and attach ng tube to side ¿b¿.3.Attach suction tube to side ¿a¿ if suction is desired.4.To administer medication, remove cap.Attach syringe to sideport, push and twist until tight and turn valve to position four.Flush valve per facility protocol following administration.5.Return valve to position one when complete to avoid leakage.Instructions for the statlock® nasogastric stabilization device (when included): remove oil and moisturizer from targeted skin area.Apply skin prep to targeted statlock® stabilization device area for skin protection and enhanced pad adherence.Allow to dry completely.Caution: federal (u.S.A.) laws restricts this device to sale by or on the order of a physician.Sterile unless package is opened or damaged, except for any individually packaged components within the pouch which are not labeled as sterile.These components are not terminally sterilized.Single use.Do not resterilize.The statlock® stabilization device does not contain natural rubber latex.Note: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations." correction: b,d,f,h 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 there was a recent incident where one of their providers was using en0046160 for decompression.Unfortunately, they had an event in which one of these bard tubes was placed in a patient who was actively coding.They were unable to decompress the patient¿s stomach and ended up using scissors to cut the end of it off to connect suction.In doing so, the crisis nurse also had gastric contents sprayed all over them.They were aware that there were adapter options but stated they could not decompress through the small enfit hole.They would assume this tube would also have problems in other situations, such as bleeding or poisoning situations.This was a major patient safety event.If the product was unable to do what it was supposed to do, they had a problem.No medical intervention was reported.Per follow up via email on (b)(6) 2023, it was reported that the sample was discarded.They did not think the bard solution would meet the anesthesiologists¿ needed in an emergency.Also stated that this tube was needed during a code.Ultimately because the staff didn¿t have the adapters, they needed to cut off the fixed enfit adapter to utilize the suction feature.There was concern of the diameter of the enfit salem sumps for suctioning blood clots, food particles, pills, etc.

• Brand Name: BARD® NASOGASTRIC SUMP TUBE WITH PREVENT® ANTI-REFLUX FILTER WITH ENFIT¿
• Type of Device: NASOGASTRIC 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: 17086018
• MDR Text Key: 317259558
• Report Number: 1018233-2023-04114
• Device Sequence Number: 1
• Product Code: FEG
• UDI-Device Identifier: 00801741113253
• UDI-Public: (01)00801741113253
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EN0046160
• Device Catalogue Number: EN0046160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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