MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) CORTRAK2; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number 40-9431TRAK2

Device Problem Unintended Movement (3026)

Patient Problem Pyrosis/Heartburn (1883)

Event Date 04/26/2022

Event Type  malfunction  

Event Description

Cortrak inserted (b)(6) 2022.Patient having increase in reflux.On cxr (b)(6) 2022, noted cortrak ballooned out.Malfunction of the tube.Discontinued that day.Patient in icu for covid pneum.Cxr already showed lung white out.Unable to determine if this negatively impacted patient.Patient expired within 72 hours of discovery.Fda safety report id # (b)(4).

• Brand Name: CORTRAK2
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 14513013
• MDR Text Key: 293146583
• Report Number: MW5109909
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 40-9431TRAK2
• Device Lot Number: 30162261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic