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

Model Number	44600
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Peg kit wire had a knot as it was being pulled from the stomach.

• Brand Name: MIC SAFETY PEG KIT - PUSH METHOD
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 16183373
• Report Number: 16183373
• Device Sequence Number: 16727277
• Product Code: KNT
• UDI-Device Identifier: 00350770446004
• UDI-Public: 00350770446004
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/07/2022
• Report Date (Section F): 12/29/2022

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: 44600
• Device Catalogue Number: 8170-20
• Device Lot Number: 30201621
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2023
• 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: Female
• Patient Weight: 72 KG
• Patient Race: Asian
• Date Report Sent to FDA: 12/29/2022