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

Model Number 40979

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

Event Date 10/23/2023

Event Type  malfunction  

Event 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
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 18989990
• MDR Text Key: 338762970
• Report Number: 18989990
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770409795
• UDI-Public: (01)00350770409795
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 11/29/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1