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

Model Number	45757
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A female patient with acute hypoxic respiratory fail, septic shock, multiple sclerosis (ms) and protein malnutrition.Nurse could not remove guide-wire after insertion of feeding tube.Verified with nurse that tube was not flushed prior to insertion.She tried to flush after insertion and had difficulty, then could not remove guide-wire.Had to remove 10 french tube and reinsert another.

• 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: 9375523
• Report Number: 9375523
• Device Sequence Number: 11529798
• Product Code: KNT
• UDI-Device Identifier: 10680651457575
• UDI-Public: (01)10680651457575(20)01(17)240701(10)00
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/05/2019
• Report Date (Section F): 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 45757
• Device Catalogue Number: 20-7431
• Device Lot Number: 0002999800
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 11/26/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 111
• Date Report Sent to FDA: 11/05/2019