MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE 10FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number 40-7431

Device Problems Break (1069); Complete Blockage (1094)

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

Event Date 03/10/2023

Event Type  malfunction  

Event Description

Feeding tube (nasal gastric tube) clogged, day shift rn used clog buster and small syringe.Tube functional again by night shift, tube feeding hung.Next day, feeding stopped (intermittent feeding at night) and flushed.2 hours later meds attempted to be given via ft, but it was again clogged.Rn attempted to unclog with warm water and 5cc syringe, and then clog zapper(avanos) was used by resource rn when that was unsuccessful.After clog zapper, rn was able to flush with 5cc syringe.When attempt made to flush with 60 cc syringe, water came out patient's nose.Team made aware of above events and suspected broken tube.Tube was removed per order and was indeed broken.Ent consulted by primary team, who was able to remove remaining portion of ft.No patient harm was noted.

• Brand Name: CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE 10FR
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 16597413
• MDR Text Key: 311831125
• Report Number: 16597413
• Device Sequence Number: 1
• Product Code: KNT
• 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: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 40-7431
• 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: 03/16/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28835 DA
• Patient Sex: Male