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

Model Number	20-0950
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	10/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of (b)(6) 2019 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, inc.Complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported the feeding tube perforated the patient¿s hiatal hernia during insertion on (b)(6) 2019.It was identified two days later, on (b)(6) 2019, when the patient¿s stomach was distended and a computed tomography ct scan was ordered.The patient required emergent surgical intervention.Additional information received 30-oct-2019 stated the nurse frequently did cortrak retracing's and also forgot to select "end" before pulling the stylet out.The risk management personnel did not blame the clinician or the cortrak device for the complication.They don¿t know when the perforation occurred and it may have been from other procedures.Radiology also read the radiology exam results noting the tip was in the incorrect position.Additional information received 01-nov-2019 stating the patient was "stable but very ill.".
Additional Manufacturer Narrative
Correction: d4.The device history record for the reported lot number, 0203018739, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 28-feb-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.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, inc.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.

• Brand Name: CORTRAK 2 ENTERAL ACCESS SYSTEM
• Common Device Name: DH CORTRAK (EAS)
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9357583
• Report Number: 3011270181-2019-00068
• Device Sequence Number: 16703570
• Product Code: KNT
• UDI-Device Identifier: 10680651472011
• UDI-Public: 10680651472011
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K113351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2020

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
• Operator of Device: Health Professional
• Device Model Number: 20-0950
• Device Catalogue Number: 104720102
• Device Lot Number: 0203018739
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 02/28/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 72