MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORTRAK2 NG.NI FEEDING TUBE / ELECTROMAGNETIC TRNSM STYLET / ENFIT CONN COFIT; DH CORTRAK DISPOSABLES

Model Number 40-9551TRAK2

Device Problems Complete Blockage (1094); Material Fragmentation (1261); Material Rupture (1546)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/03/2021

Event Type  malfunction  

Event Description

It was reported that the nasogastric (ng) tube became blocked and then was found to be ruptured with a 20 inch piece broken off in the patient.The patient was in the hospital icu for to complications due to covid related pneumonia.The ng tube was in place for at least 5-7 days.It was determined that the ng tube had clogged, and clog zapper was used to clear the clog and feedings resumed.The following day a routine x ray was performed which showed the tube in two pieces.A kidney, ureter, and bladder (kub) x-ray was ordered to confirm.The physician ordered that the proximal end be removed and the broken off distal end to be allowed to pass naturally.The patient passed away on (b)(6) 2021 due to complications of covid, unrelated to the reported event.Per additional information received on 30 sep 2021, the ng tube had been placed on (b)(6) 2021.The reported event occurred on (b)(6) 2021.

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 not possible as the lot number involved in the reported incident was not known by the reporter.All information reasonably known as of 06 oct 2021 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).

Manufacturer Narrative

Per review it was determined that the original alert date was 22 sep 2021, not 23 sep 2021.The initial report should then be 22 sep 2021.One used sample was returned for evaluation.A split in the device was identified at the 19cm marking.Additionally the tubing appeared to have ballooned at that point, which burst resulting in the split.The distal end was not returned with the sample.There was no foreign material build up noted in the tube.The complaint is confirmed as reported.Root cause was determined to be most likely use related.As per the ifu, vigorous force should not be used to irrigate, administer liquids, or unblock the tube.All information reasonably known as of 19 nov 2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).

• Brand Name: CORTRAK2 NG.NI FEEDING TUBE / ELECTROMAGNETIC TRNSM STYLET / ENFIT CONN COFIT
• 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: 12590959
• MDR Text Key: 281089170
• Report Number: 9611594-2021-00140
• 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: Other,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2021

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
• Device Operator: Health Professional
• Device Model Number: 40-9551TRAK2
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 10/07/2021
• Supplement Dates Manufacturer Received: 11/01/2021
• Supplement Dates FDA Received: 11/22/2021
• 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
• Treatment: CLOG ZAPPER
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 103 KG