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

Model Number	40983
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The 17-gauge introducer safety needle in the peg (percutaneous endoscopic gastrostomy) kit that was opened caused the catheter to be shredded and was not able to be used.Another kit was opened, there was damage, but the wire was able to be passed through.No harm to patient.

• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 21592716
• Report Number: 21592716
• Device Sequence Number: 12844799
• Product Code: KNT
• UDI-Device Identifier: 00350770409832
• UDI-Public: (01)00350770409832
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/06/2025
• Report Date (Section F): 03/06/2025

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: 40983
• Device Catalogue Number: 7180-24
• Device Lot Number: 30308229
• 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: 03/13/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2025
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Date Report Sent to FDA: 03/06/2025