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 Problems Abdominal Pain (1685); Internal Organ Perforation (1987)

Event Date 02/27/2021

Event Type  Injury  

Manufacturer Narrative

Avanos has reached out to the customer to attempt to receive the device and tracings for evaluation, however at this time, the device and tracings have not been received.A review of the device history record is in-progress.All information reasonably known as of 23 mar 2021 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.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.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 comp-(b)(4).

Event Description

It was reported that a stomach perforation occurred during the use of a cortrak device.Per additional information received 5 mar 2021, the tube had been placed by a registered nurse at the bedside.Upright abdominal series x-ray did not reveal free air, and the order was given to use the tube.The patient tolerated tube feeding for two hours, but did not tolerate a water flush of the tube.The patient reported abdominal pain.Assessment of the area reveal distension and tenderness to palpitation and patient developed tachycardia.A ct of the abdomen and pelvis revealed moderate free air and perforation at the gastric cardia.The family decline surgical intervention and transitioned the patient to hospice care.The cortrak device appeared to be functioning normally and the tracings were reviewed, however, no data has been provided to avanos at this time.

Manufacturer Narrative

The device history record for lot 1303032 was reviewed and the product was produced according to product specifications.All information reasonably known as of 28 apr 2021 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.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.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).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.

• Type of Device: DH CORTRAK (EAS)
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11556933
• MDR Text Key: 252237532
• Report Number: 3011270181-2021-00017
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770472010
• UDI-Public: 00350770472010
• Combination Product (y/n): N
• PMA/PMN Number: K113351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

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: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 03/23/2021
• Supplement Dates Manufacturer Received: 04/26/2021
• Supplement Dates FDA Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SMART RECEIVER UNIT ¿ S/N (B)(6); UNKNOWN NASOGASTRIC TUBE
• Patient Outcome(s): Required Intervention
• Patient Age: 93 YR
• Patient Weight: 38