MAUDE Adverse Event Report: AVANOS MEDICAL, INC. CORFLO NASOGASTRIC NASOINTESTINAL PEDIATRIC FEEDING TUBE WITH STYLET WITH ENFIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 40-8366

Device Problems Complete Blockage (1094); Peeled/Delaminated (1454)

Patient Problems Vomiting (2144); Foreign Body In Patient (2687)

Event Date 02/19/2022

Event Type  Injury  

Event Description

Patient had nasogastric tube (ngt).Noted to have episodes of ngt being clogged, eventually flushed/cleared with soda.He vomited the tube out around day +4; per parents report it was noted that the tip of the ngt seemed flayed at the end.He has had subsequent ngts.Approximately 12 days later, he had a x-ray taken for placement of another ngt.Radiology report commented that there appeared to be a part of a tube that maybe external to the patient.Follow-up x-ray confirmed that he had a piece of ngt in his small intestines.The patient himself has had about 48 hours of straining and seeming uncomfortable with stooling.Approximately 3 days later , the patient underwent a colonoscopy with gi, where providers were unable to retrieve the object from the patient's small intestine.The piece was extracted in the or via laparoscopic surgery.

• Brand Name: CORFLO NASOGASTRIC NASOINTESTINAL PEDIATRIC FEEDING TUBE WITH STYLET WITH ENFIT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 14371236
• MDR Text Key: 291486273
• Report Number: 14371236
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 40-8366
• Device Catalogue Number: 40-8366
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Age: 365 DA
• Patient Sex: Male