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

Patient Problems Failure of Implant (1924); Peritoneal Laceration(s) (2003); Bowel Perforation (2668)

Event Date 08/29/2022

Event Type  Injury  

Event Description

My daughter (b)(6) was having a bladder surgery at (b)(6) hospital main campus, (b)(6) with her surgeon dr.(b)(6).During the surgery, dr.(b)(6) replaced a gastrostomy tube which was in (b)(6) appendicostomy (which she had for the malone antegrade continence enema (mace)).Dr.(b)(6) inserted a new gastrostomy tube into the appendicostomy after removing the old gastrostomy tube.The replacement tube was a mic- key brand balloon style g-button.During the replacement, the new g-tube punctured through the side of the appendix, meaning that the g-tube was now providing a conduit into the abdominal cavity instead of into the colon as intended.This error was not noticed until about a week later, after lots of saline and multiple doses of laxatives (mineral oil, etc.) had been inserted through the g-tube, unknowingly filling my daughter's abdominal cavity with these substances.I am making this report because i am not sure if g-tubes are technically approved to be inserted through appendicostomies.I doubt that they are.I don't mind doctors using them this way, but if they are going to be used this way, i believe there should be a warning issued so that doctors know about this potential problem.It took the doctors a very long time to realize the problem, and it seems like they might have realized it sooner if they had understood the potential risk of puncturing the appendicostomy with the g-tube.Multiple medical conditions that are not related to this surgical error in this report.I can provide more info if needed.Multiple prescriptions that are not related to this surgical error in this report.I can provide more info if needed.

• Brand Name: MIC-KEY GASTROSTOMY LOW-PROFILE FEEDING TUBE, BALLOON STYLE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 18060301
• MDR Text Key: 327473037
• Report Number: MW5147677
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability; Required Intervention
• Patient Age: 7 YR
• Patient Sex: Female
• Patient Weight: 22 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White