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

Model Number 0046160

Device Problems Misassembled (1398); Deformation Due to Compressive Stress (2889)

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 ng tube was kinked at the end.The hospital had numerous difficulties with numerous patients.In addition, they had difficulty inserting them.The doctor was unable to place one of the ng tubes.Another doctor was able to place one after icing the first 6 cm or so, with some difficulty.The doctor stated that these tubes appear to have multiple openings, with one large one, and they didn't remember there being so many.

Manufacturer Narrative

The device was not returned for evaluation.The reported event could not be confirmed.A potential failure mode could be ¿poor flow rate or suction¿ with a potential root cause of "dimensions not designed correctly".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: ¿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.Confi rm tube placement per hospital policy.The tube has a radiopaque stripe facilitating x-ray confi rmation.If proper placement of tube within the stomach cannot be confi rmed, remove the tube gently and start the procedure again.8.Secure with a securement device or tape per hospital protocol.9.Ensure 5-in-1 adapter or lopez valve 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 refl ux 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-refl ux filter 1.Firmly seat the tapered end of anti-refl ux fi lter 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 syringe to luer fi tting on anti-reflux fi lter and inject a minimum of 15cc of air to clear the blue air vent lumen of any gastric reflux.Do not inject fluid through fi lter.3.To cap nasogastric tube when tube is not connected to a suction source insert transport plug on anti-refl ux fi lter housing into suction lumen of nasogastric tube.Instructions for lopez valve (when included): 1.Attach medication port cap to side ¿c¿.2.Turn valve to position one.3.Attach suction tube to side ¿a¿ and push together fi rmly.4.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.5.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.6.Return valve to position one when complete to avoid leakage." 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.H3 other text : the device was not returned.

Event Description

It was reported that the ng tube was kinked at the end.The hospital had numerous difficulties with numerous patients.In addition, they had difficulty inserting them.The doctor was unable to place one of the ng tubes.Another doctor was able to place one after icing the first 6 cm or so, with some difficulty.The doctor stated that these tubes appear to have multiple openings, with one large one, and they didn't remember there being so many.

• 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: 10004439
• MDR Text Key: 189297629
• Report Number: 1018233-2020-02869
• 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: 06/17/2020

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 Expiration Date: 02/29/2024
• Device Model Number: 0046160
• Device Catalogue Number: 0046160
• Device Lot Number: NGDP0649
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/07/2020
• Initial Date FDA Received: 04/28/2020
• Supplement Dates Manufacturer Received: 05/28/2020
• Supplement Dates FDA Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1