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

Model Number 45879

Device Problem Failure to Advance (2524)

Patient Problem Insufficient Information (4580)

Event Date 06/03/2021

Event Type  malfunction  

Event Description

During the procedure, the guide wire could not be placed through the catheter.This has happened with two other kits that had the same lot number.This is a substitution product for a product normally stocked.

• Brand Name: AVANOS
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward pkwy; alpharetta GA 30004
• MDR Report Key: 12149124
• MDR Text Key: 260950184
• Report Number: 12149124
• 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: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 45879
• Device Catalogue Number: 30-5020
• Device Lot Number: 9110919
• 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: 06/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 8760 DA
• Patient Weight: 82