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

Model Number 461243

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Date 11/10/2020

Event Type  malfunction  

Event Description

A kangaroo feeding tube with iris technology was placed via the patient's left nostril.A confirmation x-ray was ordered.The portable x-ray was performed at 1930 and the radiology confirmation was completed at 2129 stating, "esophagogastric tube terminates in the body of the stomach." an assessment and start of the tube feeding were documented in the lda flowsheet at 2219.The patient refused to eat or take po medications but was agreeable to po medications being given via feeding tube.She tolerated the feeding well overnight.Feeding tube assessments, feedings and flushes continued to be documented every shift.5 days later, it was also noticed that the stylet was still in place and it was removed.The feeding tube was replaced the next day and placed in the right nostril.The patient was discharged eight days later, and her feeding tube was removed prior to discharge.The cap on the stylet of the kangaroo feeding tube with iris technology is the same color as the body of the feeding tube.There are no special markings or coloring to indicate a stylet.

• Brand Name: KANGAROO
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 12084071
• MDR Text Key: 258913586
• Report Number: 12084071
• 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: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 461243
• Device Catalogue Number: 461243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/07/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 9490 DA
• Patient Weight: 39