MAUDE Adverse Event Report: AVANOS MEDICAL, INC. CORFLO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 46188

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

Event Date 02/06/2024

Event Type  malfunction  

Event Description

During bedside placement of feeding tube the guidewire started to unravel.It was removed with great difficulty without any obvious trauma to the patient.Upon further examination of the guidewire, the tip of the tubing was in the shape of an accordion.A new kit was opened, and the tube was placed.Per md, this has happened in the past.We will continue to track and trend these events.Product information: avenos (corflo) percutaneous endoscopic gastrostomy peg kit 20fr.Lot- 30279092, ref- 50-4020.

• Brand Name: CORFLO
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 18865042
• MDR Text Key: 337205791
• Report Number: 18865042
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 46188
• Device Catalogue Number: 50-4020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/19/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 60 KG
• Patient Race: Black Or African American