MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORTRAK 2 NG/NI FT WITH ELECTROMAGNETIC TRANSMITTING STYLET WITH ENFIT CONNECTOR; DH CORTRAK DISPOSABLES

Model Number 40-9551TRAK2

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/23/2023

Event Type  malfunction  

Event Description

Avanos medical inc.Received a single report that referenced two different incidences, which were associated with separate units, involving two different patients.This is the second of two reports.Refer to 9611594-2023-00070 for the first report.A severed tube was reported.There was no report of patient injury or medical intervention.

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 16 may 2023 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 : device not returned.

Event Description

Additional information received 23may2023 reported, the nasogastric tube (ng) was placed on (b)(6) 2023.On (b)(6) 2023, kidney, urethra and bladder (kub) x-ray showed the corpak was severed.The tube was removed by upper gastroenterology (gi) on (b)(6) 2023, the corpak was replaced and the patient was discharged home; no patient injury was reported.

Manufacturer Narrative

All information reasonably known as of 07 jun 2023 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

Additional information: h6; h10 h6: 4247- (appropriate term/code not available): lack of cleaning of the device.The device history record for lot 30247722 was reviewed and the product was produced according to product specifications.The actual sample from the reported event was returned for evaluation, the received sample was returned with the opened original packaging, the stylet wire was also returned and received outside of the yellow tubing along with a guitar pick (non-avanos).Visual examination of the device revealed the tubing had signs of damage and discoloration (which were noted to be black), which started at the 75cm marking to the bolus tip (distal end) of the tube.An opening (tear) was identified approximately between the 82-81cm marking, at the 82-81cm marked location, the tubing appeared to have expanded to form a balloon shape which burst axially causing an opening of the tube.There were thin layers of the material noticed on the ballooned portion of the tube.Both breaking points exhibited, an unknown dried foreign material residue at the distal portion of the tubing.Testing of the sample: the tube was flushed through the y connector (proximal and distal portions) of the tube; resistance was felt while flushing at the distal portion of the tube and a couple of attempts were made to flush it; however, no substances were flushed out.The reported event could be confirmed as reported, the root cause was determined to be: user inappropriate use and/ or lack of cleaning of the device.All information reasonably known as of 11 sep 2023 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

The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.All information reasonably known as of (b)(6) 2023 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 NG/NI FT WITH ELECTROMAGNETIC TRANSMITTING STYLET WITH ENFIT CONNECTOR
• Type of Device: DH CORTRAK DISPOSABLES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V. (AVENT 1); circuito industial no.40; colonia obrera; nogales, cp
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 16949915
• MDR Text Key: 315877028
• Report Number: 9611594-2023-00071
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770460536
• UDI-Public: 00350770460536
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K821906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 40-9551TRAK2
• Device Lot Number: 30247722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 63 KG