MAUDE Adverse Event Report: AVANOS MEDICAL, INC. HALYARD MIC G FEEDING TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 94779

Device Problems Deflation Problem (1149); Fluid/Blood Leak (1250)

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

Event Date 10/26/2022

Event Type  malfunction  

Event Description

A 20 fr mic (avanos) gastrostomy tube was placed.The tube was left to drainage overnight.On the morning of the next day, it was noted that the tube was out, and the retention balloon had deflated.Testing of the balloon demonstrated that the valve leaked in the tube.

• Brand Name: HALYARD MIC G FEEDING TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 15707492
• MDR Text Key: 302777156
• Report Number: 15707492
• 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: 10/28/2022,10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 94779
• Device Catalogue Number: REF: 0100-20
• Device Lot Number: 30210607
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28105 DA
• Patient Sex: Female
• Patient Weight: 62 KG