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

Model Number	46042
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Nasogastric tube was delivered to a patient's home.Upon opening the bag that contained the tube, patient's mother discovered holes on both ends of the tube near the ports.

• Brand Name: HALYARD
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11071839
• Report Number: 11071839
• Device Sequence Number: 11652902
• Product Code: KNT
• UDI-Device Identifier: 10680651460421
• UDI-Public: (01)10680651460421
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 12/03/2020
• Report Date (Section F): 12/03/2020

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: No Information
• Device Model Number: 46042
• Device Catalogue Number: 40-9366
• Device Lot Number: 30061615
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 2 MO
• Event Location: Other
• Date Report to Manufacturer: 12/24/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 3
• Date Report Sent to FDA: 12/03/2020