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

Model Number 0270-14-1.7-22

Patient Problem Failure of Implant (1924)

Event Date 11/16/2023

Event Type  Injury  

Event Description

My son is exclusively fed via gastrointestinal tube (g-tube).We have had 2 fail on us in the last quarter.My son uses avanos mic-key g-tubes size 14 fr 1.7 cm.Our second failed us today and i left the company another report digitally and then called them due to they've never contacted me back after the first failure a couple months ago.When i spoke to them today on the phone and told them i now have two failures they said their team is behind in cases.This is unacceptable.This is a life saving device as my son solely eats via g-tube.I am formally reporting this issue as i feel my failed medical devices are not being handled in proper adequate time.It is expensive to purchase these out of pocket when insurance only covers 1 per quarter.Please aid in avanos responding properly and replacing my now two failed mic-key g-tube devices.Lot numbers 30192881 and 30257721.Your assistance is much appreciated as we are a medically complex family that cares for my son at home.Reference report: mw5148286.

• Brand Name: MIC-KEY G-TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 18171569
• MDR Text Key: 328689978
• Report Number: MW5148285
• 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: Unknown
• Type of Report: Initial
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0270-14-1.7-22
• Device Lot Number: 30257721
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: G-TUBE.; LEVOTHYROXINE HYDROCORTISONE.; OXYGEN VENTILATOR.; TRACHEOSTOMY.
• Patient Outcome(s): Required Intervention
• Patient Age: 19 MO
• Patient Sex: Male
• Patient Weight: 11 KG
• Patient Ethnicity: Non Hispanic