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

Model Number 40-9431TRAK2

Device Problem Material Integrity Problem (2978)

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

Event Date 04/06/2023

Event Type  malfunction  

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 no lot number was provided.All information reasonably known as of 16 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.

Event Description

Fda medwatch / fda user facility report mw report (b)(4) reported, ¿corflo¿ nasogastric/nasointestinal feeding tube in the stomach with irregularity and possible discontinuity highly concerning for tube fracture (complete versus partial).¿ no injury reported.Additional information received 19apr2023 reported, the radiologist reading of the x-ray reported a slight opening on the left-side of the tube.The tube was removed in one piece, by interventional radiology (ir) due to the patient being a difficult placement for bedside dobhoff tube (dht) placement.There was no patient injury; however, the frail elderly patient had to go two days without nutritional tube feed support, iv fluids were provided.

Manufacturer Narrative

The actual sample from the reported event was returned for evaluation.Visual examination of the device revealed the connector did not exhibit visible damage and the connection appeared to be secure.The tubing exhibited discoloration approximately half-way down and became darker toward the distal end, the bolus tip was attached.Ballooning of the tube was present approximately 30cm above the distal bolus tip; however, the tubing was not broken or separated.When examined under magnification, an axial split was observed in the ballooned area at the medial location of the split and the material appeared lighter and more stressed.The reported event could be confirmed as reported; the root cause was user incorrect use.All information reasonably known as of 17 jul 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): CORPAK; 5405 windward parkway; alpharetta GA 30004
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 17166917
• MDR Text Key: 317760212
• Report Number: 3011270181-2023-00060
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770460475
• UDI-Public: 00350770460475
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 40-9431TRAK2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 92 YR
• Patient Sex: Female
• Patient Weight: 43 KG