MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® NASOGASTRIC SUMP TUBE WITH ENFIT¿

Model Number	EN0042180
Medical Device Problem Codes	Incorrect Measurement (1383); Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer was having issues with the smaller bore size on the enfit connectors.The customer asked for lumen sizes of en0042180 and en0056180 as they were advising that stomach debris from patients was clogging the tubing because patients with a full stomach could not be suctioned using the enfit connector.For now, they were keeping a case of the standard version in case the enfit did not work for them.Per follow up via email received on 26may2023, customer had made it clear several times that these were merely reported events surrounding the problem of the sump tubes.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 customer was having issues with the smaller bore size on the enfit connectors.The customer asked for lumen sizes of en0042180 and en0056180 as they were advising that stomach debris from patients was clogging the tubing because patients with a full stomach could not be suctioned using the enfit connector.For now, they were keeping a case of the standard version in case the enfit did not work for them.Per follow up via email received on 26may2023, customer had made it clear several times that these were merely reported events surrounding the problem of the sump tubes.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "lumen size designed incorrectly resulting in the lumen becoming blocked during use / inadequate material selection during design phase / wall thickness of tube not adequate to maintain suction".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.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: "attention: all references to the ng tube, prevent® filter and lopez valve® hereafter are understood to be enfit¿ compatible.Read all instructions prior to use.Indications for use: bard® nasogastric sump tubes with enfit¿ connector 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: use with caution in patients with a history of head trauma, facial trauma, esophageal diseases and patients with potential for vomiting.Do not force nasogastric tube during insertions; damage to the nasal passage and mucosa and bleeding may occur.Measure insertion length carefully- excessive insertion length of tube into the stomach may lead to coiling and/or formation of tube-knot.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.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 & fluid buildup in stomach, aspiration of gastric contents, aspiration pneumonia and other complications.Do not inject fluid through the prevent® filter as this may result in blockage and leakage of filter.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 the statlock® nasogastric stabilization device (when included): remove oil and moisturizer from targeted skin area.Apply skin prep to targeted statlock® stabilization device area for skin protection and enhanced pad adherence.Allow to dry completely.Note: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Sterile unless package is opened or damaged, except for any individually packaged components within the pouch which are not labeled as sterile.These components are not terminally sterilized.Single use.Do not resterilize.Instructions for nasogastric tube insertion explain the procedure to the patient.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.Check the patient¿s nostrils for patency; select the nostril with best patency.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-reflux filter with enfit¿ connector firmly twist the white base of anti-reflux filter in blue air lumen vent of nasogastric tube.If gastric reflux in vent lumen is observed, clear the obstruction in the main lumen by following your hospital¿s standard protocol.Attach enfit¿ - compatible syringe to enfit¿ male fitting on anti-reflux filter and inject a minimum of 15cc of air to clear the blue air vent lumen of any gastric reflux.Do not inject fluid through filter.To cap nasogastric tube when tube is not connected to a suction source insert tethered cap that is attached to the barb in the suction lumen of nasogastric tube.Caution: federal (u.S.A.) laws restricts this device to sale by or on the order of a physician." 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.

• Brand Name: BARD® NASOGASTRIC SUMP TUBE WITH ENFIT¿
• Common Device Name: NASOGASTRIC SUMP TUBE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17116877
• Report Number: 1018233-2023-04262
• Device Sequence Number: 12522244
• Product Code: BSS
• UDI-Device Identifier: 00801741113819
• UDI-Public: (01)00801741113819
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

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: Health Professional
• Device Model Number: EN0042180
• Device Catalogue Number: EN0042180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown