MAUDE Adverse Event Report: Avanos Medical Inc. MIC-KEY Gastrostomy Feed Tube, Extension Sets, ENFit-14 Fr, 3-cm; DH EF Balloon Tubes Products

Model Number	8140-14-3.0
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Ulcer (2274)
Type of Reportable Event	Malfunction

• Brand Name: MIC-KEY Gastrostomy Feed Tube, Extension Sets, ENFit-14 Fr, 3-cm
• Common Device Name: DH EF Balloon Tubes Products
• 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: 50810010
• Report Number: 9611594-2026-00708
• Device Sequence Number: 8900717
• Product Code: KNT
• UDI-Device Identifier: 00350770427355
• UDI-Public: (01)00350770427355
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: 8140-14-3.0
• Device Catalogue Number: 8140-14-3.0
• Device Lot Number: 30361273
• 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: 08/18/2026
• Initial Report FDA Received Date: 09/17/2026
• 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 Age: 10 YR
• Patient Sex: Male
• Patient Weight: 61 LB