MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORTRAK 2 ENTERAL ACCESS SYSTEM; DH CORTRAK (EAS)

Model Number 20-0950

Device Problem Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 18 aug 2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).

Event Description

It was reported that a lung placement occurred at the hospital.Per additional information received on 3 aug 2020, there were no reports of medical intervention being required.Per additional information received on 8 aug 2020, as a result of the incident the staff was provided training on use of the device.The operator of the device during the reported incident attended this training and was provided additional bedside coaching.Additional information has been requested but not yet received.

• Brand Name: CORTRAK 2 ENTERAL ACCESS SYSTEM
• Type of Device: DH CORTRAK (EAS)
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): CORPAK MEDSYSTEMS, INC; 1001 asbury dr; buffalo grove IL 60089
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 10425805
• MDR Text Key: 203714826
• Report Number: 3011270181-2020-00114
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770472010
• UDI-Public: 00350770472010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20-0950
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other