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

Model Number 0046160

Device Problem Device Markings/Labelling Problem (2911)

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 depth markings were rubbing off on the ng tube.

Event Description

It was reported that the depth markings were rubbing off on the ng tube.

Manufacturer Narrative

The reported event was confirmed.The device did not meet specifications.The product was used for treatment purposes.The product was influenced by the reported failure.Visual evaluation of the returned sample noted one opened (with original packaging) and two unopened (inside original packaging), unused nasogastric sump tubes.Visual inspection of the sample noted that the black depth markings on the opened ng tube were worn and difficult to see.This is out of specification per inspection procedure, which states, "black inserting depth marks shall be printed according to drawing" and "check that the 4 square marks are present." the unopened samples were opened and observed to have distinct and dark marks.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿incorrect position of the tube." 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.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.:.

• Brand Name: BARD® NASOGASTRIC SUMP TUBE WITH PREVENT® ANTI-REFLUX FILTER WITH ENFIT¿
• Type of Device: NG TUBE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8932145
• MDR Text Key: 155790679
• Report Number: 1018233-2019-05103
• Device Sequence Number: 1
• Product Code: FEG
• UDI-Device Identifier: 00801741052323
• UDI-Public: (01)00801741052323
• 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: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 0046160
• Device Catalogue Number: 0046160
• Device Lot Number: NGCX0293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Date Manufacturer Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1