The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿tube is not made of the correct material to view blockage (color etc.), both lumens are simultaneously blocked due to inadequate lumen design".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: ¿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.".
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