MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORTRAK 2 NASOGASTRIC/NASOINTESTINAL FEEDING TUBE W ELECTROMAGNETIC TRANSMITTER; CORTRAK2 NG/NI FEEDING TUBE W/ ELECTROMAGNETIC TRANSMITTER W/ ENFIT CONNECTOR

Model Number 40-9551TRAK2.

Device Problem Fracture (1260)

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

Event Date 05/01/2020

Event Type  malfunction  

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 in-progress.All information reasonably known as of 20 may 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 feeding tube broke off in a patient.Additional information has been requested, but not yet received.Per additional information received 13 may 2020, the tube which had been placed pre-operatively then broke two weeks post-operatively.This was visualized via imaging.The imaging was done after the tube feeding returned back through the tube, to determine the position of the tube.The fracture was then visible, and the broken piece was removed via endoscopy.At no point did the tube appear to be blocked.

Manufacturer Narrative

The sample was not provided, however, the customer provided pictures of the actual sample.Evaluation of the pictures confirmed the complaint as reported.However, as physical sample was returned, no root cause could be determined.All information reasonably known as of (b)(6)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 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.H3 other text : photos of the device were provided.

Manufacturer Narrative

The device history record for lot 30014374 was reviewed and the product was produced according to product specifications.All information reasonably known as of (b)(6)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 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.

Manufacturer Narrative

Correction: per review it was determined that the product code reported was 40-9551trak2.Fields d2 and d4 have been updated accordingly.All information reasonably known as of 10 jul 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 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 NASOGASTRIC/NASOINTESTINAL FEEDING TUBE W ELECTROMAGNETIC TRANSMITTER
• Type of Device: CORTRAK2 NG/NI FEEDING TUBE W/ ELECTROMAGNETIC TRANSMITTER W/ ENFIT CONNECTOR
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10080213
• MDR Text Key: 196314718
• Report Number: 9611594-2020-00082
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10815149023936
• UDI-Public: 10815149023936
• Combination Product (y/n): N
• PMA/PMN Number: K821906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 40-9551TRAK2.
• Device Catalogue Number: N/A
• Device Lot Number: 30014374
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2020
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 73