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

Model Number 8140-14-1.2

Device Problems Deflation Problem (1149); Leak/Splash (1354); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Caller called to report that a gastrointestinal tube in patient was leaking overnight.When doctor checked and pulled the g-tube, it came out of patient, deflated and with a tear in the material.G-tube was replaced.

• Brand Name: MIC-KEY LOW PROFILE G-TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL INC., (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 16215583
• MDR Text Key: 307982672
• Report Number: MW5114414
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8140-14-1.2
• Device Lot Number: 30148923
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1