MAUDE Adverse Event Report: Avanos Medical Inc. MIC-KEY Gastrostomy Feed Tube, ENFit Connectors-12 Fr, 1cm; Tubes, Gastrointestinal (And Accessories)

Model Number	8140-12-1.0
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Other

• Brand Name: MIC-KEY Gastrostomy Feed Tube, ENFit Connectors-12 Fr, 1cm
• Common Device Name: Tubes, Gastrointestinal (And Accessories)
• 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 ; MX 84048
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; +1(470)448-5487
• MDR Report Key: 50872974
• Report Number: 9611594-2026-00711
• Device Sequence Number: 13089805
• Product Code: KNT
• UDI-Device Identifier: 00350770426983
• UDI-Public: (01)00350770426983
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K043114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Lay User/Patient
• Device Model Number: 8140-12-1.0
• Device Catalogue Number: 8140-12-1.0
• Device Lot Number: 30392989
• Was Device Available for Evaluation?: No
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 4 MO
• Patient Sex: Female
• Patient Weight: 11 LB