MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) AVANOS 18FR TRANSGASTRIC JEJUNAL FEEDING TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Lot Number 30153030

Device Problems Labelling, Instructions for Use or Training Problem (1318); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Description

We have had two instances of patients with gastric-jejuna.Tubes in place that have been fed/received medications into the wrong location due to changes in the product.The product previously had the jejunal port as the straight port and the gastric port as the side port.In a recent change by the manufacturer, the port locations have been swapped.This change has been further complicated by the rubbing off of the text that labels the ports as either gastric or jejunai.Product information: avanos 18fr transgastric-jejunal feeding tube device lot#: 30153030.(b)(4).Reference report mw5115942.

• Brand Name: AVANOS 18FR TRANSGASTRIC JEJUNAL FEEDING TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 16610400
• MDR Text Key: 312145962
• Report Number: MW5115943
• 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: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Lot Number: 30153030
• Patient Sequence Number: 1