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

Model Number	20-7432AIV2
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Upper 50¿s male in long-term acute care.Corflo feeding tube, 12 fr, inserted without difficulty.2 x-rays confirmed that the tip was kinked at a right angle.Feeding tube removed and another one inserted without difficulty.No known harm to patient.

• Brand Name: AVANOS
• Common Device Name: TUBE, FEEDING
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 15592605
• Report Number: 15592605
• Device Sequence Number: 14035422
• Product Code: FPD
• UDI-Device Identifier: 00350770457604
• UDI-Public: (01)00350770457604(240)104576002(17)261201(10)30167333
• 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): 09/20/2022
• Report Date (Section F): 09/20/2022

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: 20-7432AIV2
• Device Catalogue Number: 20-7432AIV2
• Device Lot Number: 30167333
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 10/07/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 09/20/2022