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

Model Number 0046180

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2020

Event Type  malfunction  

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 nasogastric tube inserted into the nostril, connected to the suction, then leaked at the connection of the blue tube and clear tube.The tube was initially placed for a distal small bowel obstruction.The patient required placement for a second nasogastric tube.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause could be due to "incorrect design of diameter at the end of the lumen (luer syringe) incorrect, non-uniform thickness at funnel end¿.The device was used for treatment, though it was unknown if the device was related to the reported event or met specifications since a sample was not returned.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: "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.Refl ux of gastric contents into the blue vent lumen indicates that the suction lumen is obstructed or suction is too low.Routinely check for refl ux in the blue vent lumen and clear as per applicable directions.Failure to clear the obstruction or clear prevent® filter may cause gas and fluid buildup in stomach, aspiration of gastric contents, aspiration pneumonia and other complications.6.Do not inject fl uid through the prevent® filter as this may result in blockage and leakage of fi lter.7.Monitor patient for nasal erosion, sinusitis, esophagitis, esophagotracheal fi stula, 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 fi nd 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.Confi rm tube placement per hospital policy.The tube has a radiopaque stripe facilitating x-ray confi rmation.If proper placement of tube within the stomach cannot be confi rmed, remove the tube gently and start the procedure again.8.Secure with a securement device or tape per hospital protocol.9.Ensure 5-in-1 adapter or lopez valve 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 refl ux of stomach fluids into the blue lumen.11.Do not clamp air vent port while suction is being applied." h11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.

Event Description

It was reported that the nasogastric tube inserted into the nostril, connected to the suction, then leaked at the connection of the blue tube and clear tube.The tube was initially placed for a distal small bowel obstruction.The patient required placement for a second nasogastric tube.

• Brand Name: BARD NASOGASTRIC SUMP TUBE WITH PREVENT ANTI-REFLUX FILTER
• Type of Device: NASOGASTRIC TUBE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11044496
• MDR Text Key: 222640854
• Report Number: 1018233-2020-21847
• Device Sequence Number: 1
• Product Code: FEG
• UDI-Device Identifier: 00801741052347
• UDI-Public: (01)00801741052347
• Combination Product (y/n): N
• PMA/PMN Number: K960176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 0046180
• Device Catalogue Number: 0046180
• Device Lot Number: NGDP2604
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/14/2020
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other