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

Model Number 0046180

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

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.

Event Description

It was reported that the nasogastric tube had a hole in the tube where the blue port connected.

Event Description

It was reported that the nasogastric tube had a hole in the tube where the blue port connected.

Manufacturer Narrative

The reported event was confirmed with the cause unknown.Visual evaluation of the returned sample noted one opened (without original packaging) nasogastric sump tube and a cut nasogastric sump tube.Visual inspection of the samples noted no obvious visible defects.Both tubes were flushed with methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) with no leaks noted.When one end was pinched to allow flow through the blue lumen, both tubes leaked where the blue lumen was inserted into the clear lumen.No leaks are allowed between the lumens of nasogastric tube.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be inadequate solvent bond.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 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 and 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" 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.

• 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: 8497573
• MDR Text Key: 141460747
• Report Number: 1018233-2019-01798
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• 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: 03/29/2019
• Date Manufacturer Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1