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

Model Number 42699

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 01/09/2023

Event Type  malfunction  

Event Description

G-tube balloon popped and the tube had dislodged.

• Brand Name: AVANOS
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharettta GA 30004
• MDR Report Key: 16521022
• MDR Text Key: 311056114
• Report Number: 16521022
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2023,02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 42699
• Device Catalogue Number: 8140-12-1.2
• Device Lot Number: 30228117
• 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: 03/03/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 180 DA
• Patient Sex: Male
• Patient Weight: 5 KG
• Patient Ethnicity: Hispanic