MAUDE Adverse Event Report: AVANOS MEDICAL, INC.(FORMERLY HALYARD HEALTH INC.) MIC-KEY GASTROSTOMY FEEDING TUBE, LOW-PROFILE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Lot Number 30237377

Device Problems Leak/Splash (1354); Device Dislodged or Dislocated (2923)

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

Event Date 03/03/2023

Event Type  malfunction  

Event Description

G-tube balloon was leaking and caused the g-tube to dislodge.

• Brand Name: MIC-KEY GASTROSTOMY FEEDING TUBE, LOW-PROFILE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.(FORMERLY HALYARD HEALTH INC.); 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 16610226
• MDR Text Key: 312161173
• Report Number: 16610226
• 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: 03/14/2023,03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 30237377
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 120 DA
• Patient Sex: Female
• Patient Weight: 5 KG
• Patient Ethnicity: Hispanic