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

Model Number 0046140

Device Problem Difficult to Open or Close (2921)

Patient Problems Nausea (1970); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2021

Event Type  malfunction  

Event Description

It was reported that the patient had arrived at the unit on admission with a clamped nasogastric tube from the emergency department and was to be reconnected to low suction for decompression, but the staff were unable to remove the clamp as it was fully lodged into the nasogastric tubing.It was then stated that the nasogastric tube clamp piece which is the white end of the blue or the white clamp piece broke off and was stuck in nasogastric tubing.Complainant stated that it broke quite easily and there was no way to avoid.Later, a metal chest tube clamp was used to remove the piece, although it was difficult.Solving the problem did not leave the patient in harm, but the nasogastric tubing remained intact and attached to low suction with success.However, the patient was becoming increasingly nauseated throughout this time as the patient remained clamped for a prolonged period prior to being able to connect the nasogastric tubing to low suction.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "error of inspector." 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: "caution: read all instructions prior to use.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 fl uid through the prevent® filter as this may result in blockage and leakage of fillter.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 patient¿s nostrils for patency; select the nostril with best patency.4.Lubricate the full length of tube to be inserted." the device was not returned.

Event Description

It was reported that the patient had arrived at the unit on admission with a clamped nasogastric tube from the emergency department and was to be reconnected to low suction for decompression, but the staff were unable to remove the clamp as it was fully lodged into the nasogastric tubing.It was then stated that the nasogastric tube clamp piece which is the white end of the blue or the white clamp piece broke off and was stuck in nasogastric tubing.Complainant stated that it broke quite easily and there was no way to avoid.Later, a metal chest tube clamp was used to remove the piece, although it was difficult.Solving the problem did not leave the patient in harm, but the nasogastric tubing remained intact and attached to low suction with success.However, the patient was becoming increasingly nauseated throughout this time as the patient remained clamped for a prolonged period prior to being able to connect the nasogastric tubing to low suction.Per email response, nurse stated that there was no impact to the patient and no medication was required for nausea.And also stated that sample was not available.

• Brand Name: BARD® NASOGASTRIC SUMP TUBE WITH PREVENT® ANTI-REFLUX FILTER
• Type of Device: NASOGASTRIC 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12909008
• MDR Text Key: 281578605
• Report Number: 1018233-2021-07651
• Device Sequence Number: 1
• Product Code: FEG
• UDI-Device Identifier: 00801741052316
• UDI-Public: (01)00801741052316
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K960176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 0046140
• Device Catalogue Number: 0046140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other