MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORTRAK 2 EAS ELECTROMAGNETIC TRANSMITTING STYLET AND CORFLO FEEDING TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 40-9368TRAK2

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)

Patient Problems Hemorrhage/Bleeding (1888); Foreign Body In Patient (2687)

Event Date 05/26/2022

Event Type  Injury  

Event Description

An 8fr cortrak 2 nasojejunal (nj) tube was found to be fractured in patient.The nj tube was placed 10 days later it was clamped, clog zapper used, meds and flush.X-ray on approximately 2 weeks later.The enteric tube appears fracture with the tip remaining at the fourth portion of the duodenum.The tube was removed with 3cm of the tube missing.Fractured enteric tube seen on imaging ; but distal portion had migrated beyond point of endoscopic retrieval.No enteral tube in place currently.Patient received prbc x 1, plt x 2 and 2 platelet transfusions due to gi bleeding.

• Brand Name: CORTRAK 2 EAS ELECTROMAGNETIC TRANSMITTING STYLET AND CORFLO FEEDING TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 15012375
• MDR Text Key: 295861409
• Report Number: 15012375
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 40-9368TRAK2
• Device Catalogue Number: 40-9368TRAK2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/12/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Age: 3285 DA
• Patient Sex: Female