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

Model Number 44600

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2022

Event Type  malfunction  

Event Description

Peg kit wire had a knot as it was being pulled from the stomach.

• Brand Name: MIC SAFETY PEG KIT - PUSH METHOD
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 16183373
• MDR Text Key: 307483394
• Report Number: 16183373
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770446004
• UDI-Public: 00350770446004
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/29/2022,12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 12/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18250 DA
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Race: Asian