MAUDE Adverse Event Report: COVIDIEN COVIDIEN FEEDING TUBE WITH IRIS TECHNOLOGY; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Device Problems Complete Blockage (1094); Fracture (1260); Material Separation (1562); Material Split, Cut or Torn (4008)

Patient Problem Pain (1994)

Event Date 11/13/2021

Event Type  malfunction  

Event Description

We have been using coviden feeding tubes with iris technology at (b)(6) medical center for 6months - 1 year.Since we began using these, they have been plagued with problems that were not present with our prior feeding tubes.They clog with tube feed formula much more easily.The enfit connectors get stuck/are very difficult to unscrew from tube feed tubing; if unable to disconnect, the feeding tube must be replaced which is painful and not without risks.The enfit connectors have simply fallen out of feeding tubes (faulty adhesive?).The connectors fracture at times when attempts are made to disconnect tubing.The soft plastic bifurcation of the feeding tube has torn during attempts at disconnection, and i have seen one incidence where it was torn but no obvious trauma had occurred.Fda safety report id # (b)(4).

• Brand Name: COVIDIEN FEEDING TUBE WITH IRIS TECHNOLOGY
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 12829196
• MDR Text Key: 280955898
• Report Number: MW5105383
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1