MAUDE Adverse Event Report: AVANOS MEDICAL, INC. AVANOS, CORTRAK 2; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number 20-95512TRAK2

Device Problems Defective Device (2588); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 09/11/2020

Event Type  malfunction  

Event Description

Nursing staff noted defective/twisted wire while inserting coretrack 2 nasogastric/nasointestinal feeding tube, 10fr/140cm.No harm to patient.Manufacturer response for coretrak ng tube, cortrak2 nasogastric/naso-intestinal feeding tube 10fr 140cm (per site reporter): avanos assigned complaint file #(b)(4) to our case and replaced local product of 37 (ea).

• Brand Name: AVANOS, CORTRAK 2
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12134206
• MDR Text Key: 260552652
• Report Number: 12134206
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 20-95512TRAK2
• Device Lot Number: 30055733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1