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

Model Number 44545

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Aspiration Pneumonitis (4455)

Event Date 01/18/2023

Event Type  malfunction  

Event Description

Patient has a dual lumen percutaneous gastro-jejunostomy that she uses to meet 100% of her nutrition needs.She has chronic dysphagia and is strict "nothing by mouth" at baseline.Patient uses jejunal port for tube feeds due to aspiration risk.The jejunal port for feeds is usually in the middle with the gastric port off to the side.Her tube was replaced by interventional radiology.The new tube now has the gastric port in the middle and the jejunal port to the side.The patient did not receive any education or notification that the ports were swapped.She has been feeding through the middle port still, but now it is feeding her stomach.She is currently admitted with multifocal pneumonia with high suspicion that aspiration has contributed.Subsequent investigation has ruled out aspiration as the source of the patient's pneumonia.However, a substitute product was provided without communication that the ports were in different positions.There was no communication to the organization from the manufacturer about the change in design.There was no communication to the patient that the tube she received had the potential to be different than what she was used to.

• 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: 16452167
• MDR Text Key: 310335957
• Report Number: 16452167
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/15/2023,02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 44545
• Device Catalogue Number: 8250-18
• Device Lot Number: 30153030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/15/2023
• Device Age: 1 MO
• Event Location: Home
• Date Report to Manufacturer: 02/28/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20075 DA
• Patient Sex: Female