C.R. BARD, INC. (COVINGTON) -1018233 BARD® NASOGASTRIC SUMP TUBE WITH PREVENT® ANTI-REFLUX FILTER; NG TUBE
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Model Number 0046160 |
Device Problems
Difficult to Insert (1316); Deformation Due to Compressive Stress (2889)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
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Event Description
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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.
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Event Description
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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.
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Manufacturer Narrative
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The device was not returned for evaluation.The reported event could not be confirmed.A potential failure mode could be ¿improperly molded, rough¿ with a potential root cause of ¿improper design of tip shape (too sharp or not smoothly molded)¿.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: ¿instructions for nasogastric tube insertion 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." 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.
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