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 Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2021

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 two naso gastric tubes were cracked.

Event Description

It was reported that two nasogastric tubes were cracked.

Manufacturer Narrative

The reported event was confirmed however the cause was unknown.One sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was not used for treatment.The product caused the reported failure.Visual evaluation of the returned photo samples noted two opened (with original packaging), unused nasogastric tubes with the lot number ngez2675 and one nasogastric tube without packaging and an unknown lot number.Visual inspection of the ngez2675 samples noted that both nasogastric tubes had cracks above where the blue lumen meets the clear lumen, which would cause a leak.The sample with the unknown lot seemed to have a wider hole rather than just a crack.This does not meet the specification as "no leaks are allowed between the lumens of nasogastric tube." a potential root cause for this failure could be ¿more than 4 laps¿.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: "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." 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 actual/suspected device was inspected.

• 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: 11825796
• MDR Text Key: 250657698
• Report Number: 1018233-2021-02793
• 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: health professional,other
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0046180
• Device Catalogue Number: 0046180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Date Manufacturer Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other