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

Lot Number 30255814

Patient Problem Insufficient Information (4580)

Event Date 09/18/2023

Event Type  malfunction  

Event Description

Ng tube placed, difficulty removing guidewire/stylet.Ripped ng tube.

• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 17885100
• MDR Text Key: 325076949
• Report Number: 17885100
• 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: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 30255814
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1