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

Model Number 42-7366

Device Problem Material Fragmentation (1261)

Patient Problems Fever (1858); Vomiting (2144)

Event Date 07/26/2021

Event Type  malfunction  

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 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.

• Type of Device: NASOGASTRIC FEEDING TUBE
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V. (AVENT 1); circuito industial no.40; colonia obrera; nogales, cp 84048 ; MX 84048
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 12590958
• MDR Text Key: 275226180
• Report Number: 9611594-2021-00141
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770460819
• UDI-Public: 00350770460819
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K821906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1 YR
• Patient Weight: 7