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

Model Number 0046180

Device Problem Partial Blockage (1065)

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

Event Date 07/22/2021

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 the nasogastric tube rolled up because they were not stiff as they used to be, and they clogged more.The defective device's catalog numbers are 0046140, 0046160 and 0046180.

Event Description

It was reported that the nasogastric tube rolled up because they were not stiff as they used to be, and they clogged more.The defective device's catalog numbers are 0046140, 0046160 and 0046180.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿tube is not made of the correct material to view blockage (color etc.), both lumens are simultaneously blocked due to inadequate lumen design".The lot number is 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." the device was not returned.

• Brand Name: BARD® NASOGASTRIC SUMP TUBE WITH PREVENT® ANTI-REFLUX FILTER
• Type of Device: NASOGASTRIC SUMP 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12288990
• MDR Text Key: 265425098
• Report Number: 1018233-2021-04773
• Device Sequence Number: 1
• Product Code: FEG
• UDI-Device Identifier: 00801741052347
• UDI-Public: (01)00801741052347
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 0046180
• Device Catalogue Number: 0046180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2022
• 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