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

Model Number 40-9431TRAK2

Device Problems Break (1069); Complete Blockage (1094); Material Fragmentation (1261); Migration or Expulsion of Device (1395)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/08/2021

Event Type  malfunction  

Event Description

Pm shift rn reported issues overnight with a clogged feeding tube.After multiple attempts to clear clog with warm water and clog zapper as per protocol to restore patency, the feeding tube was eventually deemed to be working.The tube feeds had been subsequently restarted as bile and feedings were able to be aspirated, confirming placement.The pm rn mentioned external length markings changed from what was previously documented.A kidney, ureter, and bladder (kub) x-ray was ordered and revealed that a 10 cm piece of the feeding tube had migrated to ileum.X-ray showing broken piece attached.A gi consult was obtained, and a non-contrast ct scan was ordered.The ct scan revealed that the broken tip was located at the ileoceal junction.As of next day, a kub x-ray confirmed that tip had migrated into the colon.Gi outlined plan to replace feeding tube and attempt to flush the broken tip out.Patient to be monitored for passing of fragment.If fragment is not expelled/passed a colonoscopy will be planned.Manufacturer response for nasogastric feeding tube, cortrak 2 (per site reporter).Manufacturer requested broken tube be returned for evaluation.

• 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 / CORPAK MEDSYSTEMS, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12317990
• MDR Text Key: 266383912
• Report Number: 12317990
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/12/2021

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: No Information
• Device Model Number: 40-9431TRAK2
• Device Catalogue Number: 40-9431TRAK2
• 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: 08/12/2021
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 15695 DA