MAUDE Adverse Event Report: AVANOS MEDICAL, INC. CORTRAK 2 EAS ELECTROMAGNETIC TRANSMITTING STYLET AND CORFLO FEEDING TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 40-9551TRAK2

Device Problems Fluid/Blood Leak (1250); Difficult to Remove (1528); Material Split, Cut or Torn (4008)

Patient Problem Fluid Discharge (2686)

Event Date 08/19/2021

Event Type  malfunction  

Event Description

Rn noted, while instilling medications to feeding tube, that fluid was draining from patient's nare.She noted the feeding tube to be severed at entry to nostril.Rn staff unable to able to access the remnant of the tube within the nare/oropharynx.Dr notified.Using a laryngoscope, the tube remnant was removed with magill forceps and extracted from above the vocal chords.No additional sedation was required as the patient was sedated and paralyzed prior to the event.The et tube placement was not disturbed during the removal of the remnant of the feed tube.A replacement tube was placed via cortrak.Photos available.

Event Description

Rn noted, while instilling medications to feeding tube, that fluid was draining from patient's nare.She noted the feeding tube to be severed at entry to nostril.Rn staff unable to able to access the remnant of the tube within the nare/oropharynx.Dr notified.Using a laryngoscope, the tube remnant was removed with magill forceps and extracted from above the vocal chords.No additional sedation was required as the patient was sedated and parlayed prior to the event.The et tube placement was not disturbed during the removal of the remnant of the feed tube.A replacement tube was placed via cortrak.Photos available.

• Brand Name: CORTRAK 2 EAS ELECTROMAGNETIC TRANSMITTING STYLET AND CORFLO FEEDING TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12638547
• MDR Text Key: 276599661
• Report Number: 12638547
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 40-9551TRAK2
• Device Catalogue Number: 40-9551TRAK2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/16/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 17520 DA