MAUDE Adverse Event Report: Avanos Medical Inc. MIC Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit; DH EF PEG Initial Placement Products

Model Number	9640-20
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Difficult to Remove (1528); Material Too Rigid or Stiff (1544)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Type of Reportable Event	Malfunction

• Brand Name: MIC Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit
• Common Device Name: DH EF PEG Initial Placement Products
• Manufacturer (Section D): Avanos Medical Inc.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): Avent S. de R.L. de C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana b.c. 22116 ; MX 22116
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; +1(470)448-5487
• MDR Report Key: 50844163
• Report Number: 2026095-2026-00093
• Device Sequence Number: 10461475
• Product Code: KNT
• UDI-Device Identifier: 00350770446431
• UDI-Public: (01)00350770446431
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K924065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: Health Professional
• Device Model Number: 9640-20
• Device Catalogue Number: 9640-20
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/21/2026
• 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: Unknown