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

Catalog Number 0046180

Device Problems Leak/Splash (1354); Incorrect Measurement (1383); Failure to Advance (2524)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the port on the ng tube was too small, making it difficult for crushed medicines to go through the tubing.The complainant reported that as a result of the port being too small, it clogged easily and took more water to flush (allegedly up to 100cc per administration).The smaller port also resulted in the gi juices being backed up in the blue air port that made it difficult to flush back and caused it to leak.

Manufacturer Narrative

The device was not returned for evaluation.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: ¿warnings check routinely for reflux in the vent lumen of the nasogastric tube.This indicates an obstructed suction lumen.Failure to either clear the obstruction, the lumen or clear the prevent filter may cause gas and fluid buildup in stomach.This may lead to aspiration of gastric contents, possibly resulting in aspiration pneumonia and other complications.Do not inject fluid through the prevent filter.This may result in blockage and leakage of filter.The patient should be monitored for the following conditions, particularly if nasogastric intubation is prolonged: nasal erosion, sinusitis, esophagitis, esophagotracheal fistula, gastric erosion, and pulmonary and oral infections.Instructions for nasogastric tube.Lubricate tube before insertion.Insert tube per current hospital protocol.Ensure 5-in-1 adapter or lopez valve is snugly inserted into suction lumen to prevent suction loss.For best results, keep blue lumen above the level of the patient¿s stomach.Do not clamp air vent port while suction is being applied." the device was not returned.

Event Description

It was reported that the port on the ng tube was too small, making it difficult for crushed medicines to go through the tubing.The complainant reported that as a result of the port being too small, it clogged easily and took more water to flush (allegedly up to 100cc per administration).The smaller port also resulted in the gi juices being backed up in the blue air port that made it difficult to flush back and caused it to leak.

• Brand Name: BARD® NASOGASTRIC SUMP TUBE WITH PREVENT® ANTI-REFLUX FILTER
• Type of Device: NG TUBE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7980488
• MDR Text Key: 124355410
• Report Number: 1018233-2018-04850
• 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: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0046180
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/25/2018
• Initial Date FDA Received: 10/18/2018
• Supplement Dates Manufacturer Received: 11/08/2018
• Supplement Dates FDA Received: 11/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1