MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORTRAK 2 NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH ELECTROMAGNETIC TRANSMITR; DH CPK ANTI-IV (AIV) FEEDING TUBES

Model Number	20-9558TRAK2A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/27/2022
Type of Reportable Event	Serious Injury
Additional 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 16-feb-2022 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 "after clearing a clog the cortrak team nurses attempted a retrace and discovered that the tube had burst and was in two pieces, one piece was removed and approximately 45cm of the tube remains in the patients small bowel." it was unknown at that time if any of the stylet came out of the feeding tube inside the patient when attempting the retrace or if there is a patient injury, the patient was being monitored additional information received 03-feb-2022 stating the device was in place for approximately 19-hours.The medical team removed the remaining portion of the tube using endoscopy.It was ensure whether the clinicians infused tube feeds overnight, but the only medication given was liquid tylenol and one unknown crushed medication.The background information the clinicians reported noted the tube clogged after medications were infused.A new nurse administered the medications.The cortrak team unclogged the tube that morning using 10ml syringe with a 14g catheter, the device unclogged easily with little pressure applied.The patient then had underwent an esophagogastroduodenoscopy (egd) and cortrak team was then called to retrace the tube.It was during the retrace that the cortrak team discovered the ruptured tube.When the cortrak team pulled the tube back to meet the end of the guidewire they noted the wire and immediately pulled the tube out.A kidney, ureter, and bladder (kub) x-ray was ordered and showed the remaining tube still in place.Again, the distal portion of the tube was removed via endoscopy.All findings of stomach and duodenum were normal.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30167343 in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The device was evaluated.The tube was observed to exhibit a complete rupture just passed the mark 45 + mark (at approximately the 45 mark).The tubing exhibited stretching or "ballooning" just proximal to the rupture.The remaining distal portion of the ng tube was not received (not returned) with the sample.The inside of the tubing did not exhibit occlusion.Thinning of the tube material was observed in the "ballooned" area of the tube.The rupture tear had splits and the tear line was not linear around the circumference of the tube ballooned area.Root cause could not be determined.All information reasonably known as of 21-mar-2022 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 NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH ELECTROMAGNETIC TRANSMITR
• Common Device Name: DH CPK ANTI-IV (AIV) FEEDING TUBES
• 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: 13573259
• Report Number: 9611594-2022-00018
• Device Sequence Number: 3769754
• Product Code: FPD
• UDI-Device Identifier: 00350770458243
• UDI-Public: 00350770458243
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K083210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 20-9558TRAK2A
• Device Catalogue Number: N/A
• Device Lot Number: 30167343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 71 KG