MAUDE Adverse Event Report: AVANOS MEDICAL, INC. MIC-KEY GASTROSTOMY FEEDING TUBE KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number 8140-12-1.0

Device Problems Material Rupture (1546); Material Perforation (2205)

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

Event Date 10/31/2022

Event Type  malfunction  

Event Description

We have had four avanos mic-key buttons rupture in the last two months.All four balloons ruptured or had a pinpoint hole.

• Brand Name: MIC-KEY GASTROSTOMY FEEDING TUBE KIT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 16146142
• MDR Text Key: 307186753
• Report Number: 16146142
• 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: 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 8140-12-1.0
• Device Lot Number: 30216521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/23/2022
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2023
• 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