MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) CORTRAK* 2; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Lot Number 30148042- TUBE AND STYLUS

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Failure of Implant (1924); Internal Organ Perforation (1987); Pneumothorax (2012)

Event Date 11/01/2021

Event Type  Injury  

Event Description

Rn attempted to place a keofeed tube at bedside.X-ray confirmation for placement showed that the tube perforated the lung and caused a left sided pneumothorax, which required a chest tube for treatment.Fda safety report id # (b)(4).

• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 13026106
• MDR Text Key: 282584517
• Report Number: MW5106141
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 30148042- TUBE AND STYLUS
• 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 Outcome(s): Life Threatening
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Race: Black Or African American