MAUDE Adverse Event Report: AVANOS MEDICAL, INC. MIC PEG TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8160-20
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Reported that the plastic sheath on the snare separated, and the snare could not work properly to do the peg [percutaneous endoscopic gastrostomy] tube.

• Brand Name: MIC PEG TUBE
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 24839189
• Report Number: 24839189
• Device Sequence Number: 9600787
• Product Code: KNT
• UDI-Device Identifier: 00350770006550
• UDI-Public: (01)00350770006550
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/08/2026
• Report Date (Section F): 04/08/2026

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: 8160-20
• Device Catalogue Number: 8160-20
• Device Lot Number: 30378743
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/08/2026