The reported event is unconfirmed since the reported failure could not be reproduced.The inspector received one used nasogastric sump tube with a catheter in the opened original packaging.A visual inspection noted no visual defects.The tubing and blue connector were flushed with methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and no leaks were noted.One end was pinched off and seal but no leaks were noted again.The product was then flushed from the blue tubing and no leaking was reported.The instructions for use were found adequate and state the following: "1.Explain the procedure to the patient.2.Carefully measure to fi nd 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.3.Check the patient¿s nostrils for patency; select the nostril with best patency.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.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.".
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