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

Model Number	0046160
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the nasogastric tube caused esophageal bleeding to the patient.The patient used the device for the first time.Also stated that the user was looking for a softer substrate than pvc and believed that it was too rough.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample returned for evaluation.A potential root cause for this failure mode could be due to inconsistent mechanical properties of material or polymer.It was unknown whether the device had met relevant specifications.The product was used for the treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number was unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: "indications for use: bard nasogastric sump tubes are intended to be used for: ¿ decompression of stomach by suction or aspiration of gastric contents.¿ short-term administration of term tube feeding, lavage fluid and medications.Contraindications: ¿ patients with known tape or adhesive allergies.Warnings 1.Use with caution in patients with a history of head trauma, facial trauma, esophageal diseases and patients with potential for vomiting.2.Do not force nasogastric tube during insertions; damage to the nasal passage and mucosa and bleeding may occur.3.Measure insertion length carefully- excessive insertion length of tube into the stomach may lead to coiling and or formation of tube knot.4.Lubricate the tube generously with water soluble lubricant prior to insertion.Do not use petroleum-based products as they may be harmful to the respiratory tract.5.Reflux of gastric contents into the blue vent lumen indicates that the suction lumen is obstructed or suction is too low.Routinely check for reflux in the blue vent lumen and clear as per applicable directions.Failure to clear the obstruction or clear prevent filter may cause gas and fluid buildup in stomach, aspiration of gastric contents, aspiration pneumonia and other complications.6.Do not inject fluid through the prevent® filter as this may result in blockage and leakage of filter.7.Monitor patient for nasal erosion, sinusitis, esophagitis, esophagotracheal fistula, gastric erosion and pulmonary & oral infections.Statlock nasogastric stabilization device: avoid contact with alcohol or acetone; both can weaken bonding of components and statlock stabilization device pad adherence.Instructions for nasogastric tube insertion 1.Explain the procedure to the patient.2.Carefully measure to find 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 patients nostrils for patency select the nostril with best patency.4.Lubricate the full length of tube to be inserted." h11: section a through f - the information provided by bd represents all 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 or Problem Description
It was reported that the nasogastric tube caused the esophageal bleeding to the patient.The patient used the device for the first time.Also stated that the user was looking for a softer substrate than pvc and believed that it was too rough.No medical intervention was reported.

• Brand Name: BARD NASOGASTRIC SUMP TUBE WITH PREVENT ANTI-REFLUX FILTER
• Common Device Name: NASOGASTRIC TUBE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11695302
• Report Number: 1018233-2021-02218
• Device Sequence Number: 16917967
• Product Code: FEG
• UDI-Device Identifier: 00801741052323
• UDI-Public: (01)00801741052323
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K960176
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 0046160
• Device Catalogue Number: 0046160
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 07/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other