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

Catalog Number 0046160

Device Problem Fluid/Blood Leak (1250)

Patient Problem 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 information provided by bard 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 bard.The device was not returned.

Event Description

It was reported that the nasogastric tube was leaking from an unknown location.

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 state the following: "instructions for nasogastric tube insertion: explain the procedure to the patient.Carefully measure to find 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.Check the patient¿s nostrils for patency; select the nostril with best patency.Lubricate the full length of tube to be inserted.Insert the tube through the nose aiming down and back.When the tube hits the pharynx, if patient is able, have him or her fl ex his/her head forward and swallow.Advance the tube as the patient swallows.If resistance is met, rotating the tube may facilitate placement.Continue to advance the tube until the marked position on the tube is reached.Do not advance beyond the marked length as coiling and or knotting of the tube in the stomach may occur.Confirm tube placement per hospital policy.The tube has a radiopaque stripe facilitating x-ray confirmation.If proper placement of tube within the stomach cannot be confirmed, remove the tube gently and start the procedure again.Secure with a securement device or tape per hospital protocol.Ensure 5-in-1 adapter or lopez valve is snugly inserted into suction lumen to prevent suction loss.Keep blue vent lumen above the level of the patient¿s stomach to prevent reflux of stomach fluids into the blue lumen.Do not clamp air vent port while suction is being applied.Recommended suction settings: always use lowest suction setting that will effectively decompress the stomach.For intermittent suction via thermotic pump, use ¿high¿ (gomco, 120mm hg).For intermittent suction via central source, set at ¿low¿ (30-40mm hg).For continuous suction, set at ¿low¿ (30-40mm hg).Increase slowly until fl ow is observed as necessary.Instructions for prevent® anti-reflux filter: firmly seat the tapered end of anti-refl ux fi lter in blue air lumen vent of nasogastric tube.If gastric reflux in vent lumen is observed, clear the obstruction in the main lumen by following your hospital¿s standard protocol.Attach syringe to luer fi tting on anti-refl ux filter and inject a minimum of 15cc of air to clear the blue air vent lumen of any gastric reflux.Do not inject fl uid through filter.To cap nasogastric tube when tube is not connected to a suction source insert transport plug on anti-reflux filter housing into suction lumen of nasogastric tube.Instructions for lopez valve (when included): attach medication port cap to side ¿c¿.Turn valve to position one.Attach suction tube to side ¿a¿ and push together firmly.For reorder codes 0056120, 0056140, 0056160, 0056180: if connection to a male connector is desired, attach universal adaptor to side a.Insert male connector into adaptor, and push together fi rmly.To administer medication, remove and store medication port cap in valve turn handle.Attach syringe to sideport, push and twist until tight and turn valve to position four.Flush valve per facility protocol following administration.Return valve to position one when complete to avoid leakage." (b)(4).The device was not returned.

Event Description

It was reported that the nasogastric tube was leaking from an unknown location.

• 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
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6833652
• MDR Text Key: 84936741
• Report Number: 1018233-2017-04549
• Device Sequence Number: 1
• Product Code: FEG
• UDI-Device Identifier: 00801741052323
• UDI-Public: (01)00801741052323
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0046160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2017
• 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