MAUDE Adverse Event Report: AVANOS MEDICAL, INC. CORFLO* NASOGASTRIC/NASOINTESTINAL FEEDING TUBE; TUBE, FEEDING

Model Number	20-7432AIV2
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Avanos nasogastric/naso-intestinal feeding tube was leaking nutritional content while in the patient.Nurse wiped liquid away, but tubing continued to leak.The feeding tube was removed and examined; there was a slit in the tubing.New feeding tube inserted, no known patient harm.

• Common Device Name: TUBE, FEEDING
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 18002614
• Report Number: 18002614
• Device Sequence Number: 7637920
• Product Code: FPD
• UDI-Device Identifier: 00350770457604
• UDI-Public: (01)00350770457604(240)104576002(17)280220(10)30245857
• 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): 10/17/2023
• Report Date (Section F): 10/17/2023

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
• Device Model Number: 20-7432AIV2
• Device Catalogue Number: 20-7432AIV2
• Device Lot Number: 30245857
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/25/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/17/2023