MAUDE Adverse Event Report: Avanos Medical Inc. CORFLO NG/NI Feed Tube with Stylet with ANTI-IV Connector; Apparatus, Pneumoperitoneum, Automatic

Model Number	20-9366AIV2
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction

• Brand Name: CORFLO NG/NI Feed Tube with Stylet with ANTI-IV Connector
• Common Device Name: Apparatus, Pneumoperitoneum, Automatic
• Manufacturer (Section D): Avanos Medical Inc.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V. (Avent 1); circuito industial no.40; colonia obrera; nogales, cp 84048
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; +1(470)448-5487
• MDR Report Key: 50872979
• Report Number: 9611594-2026-00718
• Device Sequence Number: 18470008
• Product Code: FDP
• UDI-Device Identifier: 00350770457864
• UDI-Public: (01)00350770457864
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K083210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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: 20-9366AIV2
• Device Catalogue Number: 20-9366AIV2
• Device Lot Number: 30361589
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/24/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 09/23/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female