MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO* NASOGASTRIC / NASOINTESTINAL FEEDING TUBE, STERILE, NON-WEIGHTED; NASOGASTRIC FEEDING TUBE

Model Number	42-7366
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Fever (1858); Vomiting (2144)
Date of Event	07/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer.The device history record for lot 0002988871 was reviewed and the product was produced according to product specifications.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.Device not returned.
Event or Problem Description
It was reported that the tip of the ng (nasogastric) tube broke and was lodged in the patient's abdomen.It was also reported that patient was vomiting with fever.Tube was replaced in nicu (newborn intensive care unit).On (b)(6) 2021 it was reported that the tube was replaced, and the fragment will be passed out spontaneously.On (b)(6) 2021 it was reported that the patient was discharged home on oxygen and jejunal feeding, the broken piece is still in situ with surgical plan to continue to manage conservatively.

• Common Device Name: NASOGASTRIC FEEDING TUBE
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12590958
• Report Number: 9611594-2021-00141
• Device Sequence Number: 3078901
• Product Code: KNT
• UDI-Device Identifier: 00350770460819
• UDI-Public: 00350770460819
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K821906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2024
• Device Model Number: 42-7366
• Device Catalogue Number: N/A
• Device Lot Number: 0002988871
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 YR
• Patient Weight: 7