MAUDE Adverse Event Report: AVANOS MEDICAL, INC. AVANOS MIC SAFETY PEG KIT - PULL METHOD; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	40979
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor was performing a bedside percutaneous endoscopic gastrostomy (peg) procedure.While removing the retrieval snare, the snare broke off and doctor had to manually retrieve the item.

• Brand Name: AVANOS MIC SAFETY PEG KIT - PULL METHOD
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 18989990
• Report Number: 18989990
• Device Sequence Number: 3038155
• Product Code: KNT
• UDI-Device Identifier: 00350770409795
• UDI-Public: (01)00350770409795
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/29/2023
• Report Date (Section F): 11/29/2023

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: 40979
• Device Catalogue Number: 7180-20
• Device Lot Number: 30266302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2024
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/29/2023