MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) CORTRAK ENTERAL ACCESS SYSTEM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Patient Problem Insufficient Information (4580)

Event Date 09/13/2023

Event Type  malfunction  

Event Description

During medication administration, it was noted that the tubing was dilating and nothing was passing.Upon inspection noted that there is a defect inside the tubing, causing a blockage.

• Brand Name: CORTRAK ENTERAL ACCESS SYSTEM
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.); alpharetta GA 30004
• MDR Report Key: 17773285
• MDR Text Key: 323813731
• Report Number: MW5145823
• 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: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Female