MAUDE Adverse Event Report: AVANOS MEDICAL, INC. AVANOS; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 40-9438

Device Problem Material Rupture (1546)

Patient Problem Aneurysm (1708)

Event Date 11/08/2022

Event Type  malfunction  

Event Description

Infant was intubated.On chest x-ray exam radiologist noted dilatation/ballooning at the cervical portion of the corflo* nasogastric/nasointestinal (ng) feeding tube.A second x-ray completed for concern for nasogastric (ng) tube rupture which showed focal discontinuity of the corflo* tube at the level of the thoracic inlet.Ng tube removed in its entirety showing aneurysmal section with lumen exposed.

• Brand Name: AVANOS
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 15876689
• MDR Text Key: 304460982
• Report Number: 15876689
• 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: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 40-9438
• Device Catalogue Number: 40-9438
• Device Lot Number: 30208011
• 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: 11/09/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 180 DA
• Patient Sex: Male
• Patient Weight: 9 KG