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

Model Number EN0046120

Device Problems Fluid/Blood Leak (1250); 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 a nasogastric tube leaked from a hole by the vent port.The patient had a nasogastric tube placed in the emergency department.On arrival to the nursing unit, the tube was found to be leaking from a hole by the vent port.The tube was replaced and no patient harm was reported.The additional information received via email states a second nasogastric tube from the same lot has the same issue but was discarded.

Event Description

It was reported that a nasogastric tube leaked from a hole by the vent port.The patient had a nasogastric tube placed in the emergency department.On arrival to the nursing unit, the tube was found to be leaking from a hole by the vent port.The tube was replaced and no patient harm was reported.It was later reported via email stated a second nasogastric tube from the same lot has the same issue but was discarded.

Manufacturer Narrative

The reported event was confirmed.The device was used for treatment.Visual evaluation of the sample noted one opened nasogastric tube within an opened original packaging.Visual inspection of the sample noted no obvious visible defects.The clear tubing of the nasogastric tubing was flushed through the wider end and was able to flow out of the eyelets.It was noted that there was a small hole between the clear and blue lumen.No damaged or missing components are allowed.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 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: ¿4.Lubricate the full length of tube to be inserted.5.Insert the tube through the nose aiming down and back.When the tube hits the pharynx, if patient is able, have him or her flex his/her head forward and swallow.Advance the tube as the patient swallows.If resistance is met, rotating the tube may facilitate placement.6.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.7.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.8.Secure with a securement device or tape per hospital protocol.9.If applicable, ensure the lopez valve® with enfit¿ connector is snugly inserted into suction lumen to prevent suction loss.10.Keep blue vent lumen above the level of the patient¿s stomach to prevent reflux of stomach fluids into the blue lumen.11.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 flow is observed as necessary.Instructions for prevent® anti-reflux filter with enfit¿ connector 1.Firmly twist the white base of anti-reflux filter in blue air lumen vent of nasogastric tube.2.If gastric reflux in vent lumen is observed, clear the obstruction in the main lumen by following your hospital¿s standard protocol.Attach enfit¿ - compatible syringe to enfit¿ male fitting on anti-reflux filter and inject a minimum of 15cc of air to clear the blue air vent lumen of any gastric reflux.Do not inject fluid through filter.3.To cap nasogastric tube when tube is not connected to a suction source insert tethered cap that is attached to the barb in the suction lumen of nasogastric tube." correction: d4, e4.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: NASOGASTRIC TUBE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9214246
• MDR Text Key: 169731274
• Report Number: 1018233-2019-06622
• Device Sequence Number: 1
• Product Code: FEG
• UDI-Device Identifier: 00801741113239
• UDI-Public: (01)00801741113239
• 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: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EN0046120
• Device Catalogue Number: 0046160
• Device Lot Number: NGDS2371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Date Manufacturer Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 77