MAUDE Adverse Event Report: AVANOS MEDICAL, INC. HALYARD; TUBE, FEEDING

Model Number	45758
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
An elderly female patient with a history of obstructive lung disease required dobhoff feeding tube insertion per protocol.Unable to remove guidewire.The end plastic piece on the guidewire broke off, so the entire tube had to be removed and replaced.Tube and packaging were kept.

• Brand Name: HALYARD
• Common Device Name: TUBE, FEEDING
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9213486
• Report Number: 9213486
• Device Sequence Number: 10862393
• Product Code: KNT
• UDI-Device Identifier: 10680651457582
• UDI-Public: (01)10680651457582
• 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): 10/01/2019
• Report Date (Section F): 10/01/2019

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: Health Professional
• Device Model Number: 45758
• Device Catalogue Number: 20-7431AIV2
• Device Lot Number: 0002999787
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 10/21/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 39
• Date Report Sent to FDA: 10/01/2019