MAUDE Adverse Event Report: AVANOS MEDICAL, INC. JEJUNAI FEEDING TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 12 FRENCH

Device Problems Failure to Advance (2524); Defective Device (2588)

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

Event Date 10/13/2022

Event Type  malfunction  

Event Description

Patient scheduled for replacement of non-functioning j-tube.The patient was taken to interventional radiology and the existing jejunostomy tube was injected with contrast demonstrating appropriate position in the jejunum.The tube was accessed with a 0.035 glidewire which was advanced over the wire and the tube was removed.A new 12 french jejunostomy tube was advanced over the wire and the balloon inflated within the jejunal lumen and the wire was removed.Contrast was injected through the j-tube opacifying the jejunum.The tube was secured to the skin and flushed the sliding disk would not move and could not be slid down the tube to secure to the patient.Packaging from defective device was not saved.Unable to complete information on device.

• Brand Name: JEJUNAI FEEDING TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.
• MDR Report Key: 15680561
• MDR Text Key: 302611774
• Report Number: MW5112902
• 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: 10/25/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12 FRENCH
• Device Catalogue Number: 0200-12LV
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Race: White