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.

• 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

• 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

• 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 Treatment Data

Date Received: 12/01/2021 Patient Sequence Number: 1