MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORTRAK 2 NG/NI FEED TUBE, ELECTRO STYLET, ENFIT; DH CORTRAK DISPOSABLES

Model Number 40-9431TRAK2

Device Problem Burst Container or Vessel (1074)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Avanos medical received a single report that referenced two different incidences, which were associated with separate units, involving two different patients.This is the first of two reports.Refer to 9611594-2023-00189 for the second event.It was reported the nasogastric tube ballooned and burst while inside the patient.There was no reported injury nor medical interventions reported.

Manufacturer Narrative

The actual device is reported to be available but has not been returned for evaluation.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 29-dec-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, 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.

Manufacturer Narrative

H6: investigation findings/no code: inappropriate use.The actual device was returned, and the device was evaluated.The split/tear identified approximately below the y-connector.No discoloration residue was seen at the entirety of yellow tubing.At the area of split/ tearing effect, the tubing appeared to have expanded to form a balloon shape which burst axially causing an opening to the tube.When manually pressing the tubing back together for inspection using magnification, there were expanded material noticed which appeared to be the ballooned portion of the tube.Both breaking points exhibited no dried foreign material residue.The sample provided confirmed tubing expanded to form a balloon shape which burst causing an early replacement of the tube.The instruction for use (ifu) contains recommendations for tube maintenance: ¿it is recommended the tube be irrigated every 4-hours with up to 20 ml of water (up to 10 ml for infants or children) before and after medication administration or when feeding formula is interrupted.Warning: vigorous syringe force should not be used to irrigate, administer liquids or unblock the tube." during cleaning and decontamination, a slight build-up/ discoloration from the outer tubing was tried to be remove by scrubbing the tubing with lint free towel using tergazyme and soaked in metricide solution.The tube was also flushed through the y-connector (proximal end).For this sample, no resistance was felt while flushing, no build up substances were flushed out of the tube as well after couple attempts.Liquid started to come out of the slit just below the y-connector.The root cause was inappropriate use.All information reasonably known as of 16-feb-2024 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)(6).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 FEED TUBE, ELECTRO STYLET, ENFIT
• 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: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 18421925
• MDR Text Key: 331685945
• Report Number: 9611594-2023-00188
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00035077046047
• UDI-Public: 0035077046047
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 40-9431TRAK2
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1