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

Model Number 20-0950

Device Problem Malposition of Device (2616)

Patient Problems Death (1802); Perforation (2001); Pneumothorax (2012)

Event Date 07/25/2019

Event Type  Death  

Manufacturer Narrative

The sample is reported to be available, but has not yet been received by the manufacturer.The device history record for serial number (b)(4) was reviewed and the product was produced according to product specifications.All information reasonably known as of 21 aug 2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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 halyard health complaint database and identified as complaint (b)(4).Device not returned.

Event Description

It was reported that "pt.(patient) death following placement of ngt (nasogastric tube) with cortrak eas (enteral access system -on f/u [follow-up) x-ray it was noted the tube was in the lung, the tube was immediately removed, upon removal of tube the lung deflated patient passed within hrs.(hours) of incident." additional information received on (b)(6) 2019 indicated operator "is one of our more experienced operators; the tracings following insertion looked good showing no signs of deviation." a request was made for stat kub (kidney-urinary-bladder imaging), results showing tube in the region of the lung; the tube was immediately removed, upon removal of tube the lung deflated, patient passed within 2 hrs.Of incident.Additional information received on (b)(6) 2019 indicated the exact time of tube placement was 1511 on (b)(6) 2019 with right lung placement.Time of death was 1836 (b)(6) 2019; cause of death is listed as "pneumothorax." operator's experience is listed as "experienced (places the most in the entire organization).".

• Brand Name: CORTRAK ENTERAL ACCESS SYSTEM
• Type of Device: DH CORTRAK (EAS)
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT, INC.; 6620 s. memorial place, suite 100; tucson AZ 85756
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 8921064
• MDR Text Key: 155244386
• Report Number: 3006646024-2019-00013
• 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: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 104720104
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/22/2019
• 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): Death; Other
• Patient Age: 66 YR
• Patient Weight: 65