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

Catalog Number 8270-14-1.0-22

Patient Problems Failure of Implant (1924); Fluid Discharge (2686); Skin Inflammation/ Irritation (4545)

Event Date 09/21/2023

Event Type  malfunction  

Event Description

A gj feeding tube by avanos had a faulty balloon that required replacement.This has happened three times now.The gj tube had been in place 1 week, 1 month, and 2 weeks respectively.The ref number of the part is: 8270-14-1.0-22.We have kept the boxes of the last two and both were manufactured on 2023-07-12 and had a lot number of 30268249.All care instructions were followed, and each time the balloon spontaneously failed.This has led to fluid loss, skin irritation, an inability to continue daily activities, and a return trip to interventional radiology to replace the tube.This piece of equipment is supposed to last a minimum of 6 months.Please issue a recall as this effects the ability of people using the product to receive nutrition, hydration, and medication.Reference reports mw5147730, mw5147732.

• Brand Name: MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 18066011
• MDR Text Key: 327596007
• Report Number: MW5147731
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 8270-14-1.0-22
• Device Lot Number: 30268249
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Sex: Female
• Patient Weight: 17 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White