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

Model Number 42698

Device Problem Break (1069)

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

Event Date 10/30/2022

Event Type  malfunction  

Event Description

Patient was being changed by parent.G-tube fell out at that time.Upon inspection, balloon was noted to be broken.

• Brand Name: MIC-KEY LOW-PROFILE GASTROSTOMY
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 15975966
• MDR Text Key: 305429701
• Report Number: 15975966
• 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: 12/02/2022,11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 42698
• Device Catalogue Number: 8140-12-1.0
• Device Lot Number: 30216521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/14/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2022
• 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: 8 KG
• Patient Ethnicity: Hispanic