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

Model Number 0046140

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the ng tube leaked from where it connects to the tubing.

Event Description

It was reported that the ng tube leaked from where it connects to the tubing.

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode could be ¿lopez valve not press-fit correctly into the tube¿ with a potential root cause of ¿lack of instructions to assembly operation¿.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: " 6.Do not inject fluid through the prevent filter as this may result in blockage and leakage of filter.".

• Brand Name: BARD® NASOGASTRIC SUMP TUBE WITH PREVENT® ANTI-REFLUX FILTER
• Type of Device: NG TUBE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8577488
• MDR Text Key: 144251698
• Report Number: 1018233-2019-02301
• Device Sequence Number: 1
• Product Code: FEG
• UDI-Device Identifier: 00801741052316
• UDI-Public: (01)00801741052316
• Combination Product (y/n): N
• PMA/PMN Number: K960176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0046140
• Device Catalogue Number: 0046140
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1