MAUDE Adverse Event Report: C. R. BARD, INC. BARD NASOGASTRIC SUMP TUBE WITH PREVENT ANTI-REFLUX FILTER WITH ENFIT; TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

Model Number EN0046160

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2023

Event Type  malfunction  

Event Description

Provider attempted to place a nasogastric tube (ng tube) (the new enfit style that we have just started to carry) 16fr or 18fr.He had the first 3 ng tubes clog, was successful on the 4th tube.

• Brand Name: BARD NASOGASTRIC SUMP TUBE WITH PREVENT ANTI-REFLUX FILTER WITH ENFIT
• Type of Device: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 16761005
• MDR Text Key: 313499026
• Report Number: 16761005
• Device Sequence Number: 1
• Product Code: FEG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/31/2023,03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EN0046160
• Device Catalogue Number: EN0046160
• Device Lot Number: NGGR2656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1