MAUDE Adverse Event Report: CARDINAL HEALTH, INC. IRIS KEOFEED TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Device Problem Complete Blockage (1094)

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

Event Date 10/22/2020

Event Type  malfunction  

Event Description

Initial keofeed tube placed.Patient receiving medications that are being crushed, and administered via keofeed.1 week later, bedside nurse not able to flush medication port easily.Nurse attempted to use soda to address clog, but was unsuccessful.Keofeed removed and a new one was re-inserted by nurse.Bedside nurse called pharmacy to request medications be changed to oral solution, and was advised that they couldn't be converted.The oral pills that are being crushed currently are: aspirin, aricept, and midodrine.Keofeed replaced.

• Brand Name: IRIS KEOFEED TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 444 mcdonnell blvd.; hazelwood MO 63042
• MDR Report Key: 10800609
• MDR Text Key: 215048657
• Report Number: 10800609
• 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: 10/28/2020

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/06/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30295 DA