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

Model Number 8884711253

Device Problems Product Quality Problem (1506); Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 09/26/2022

Event Type  malfunction  

Event Description

We've identified a specific problem with the coviden kangaroo nasogastric feeding tubes, namely that when one goes to pull out the stylet that the plastic cap on the stylet will pull off.This will both create a sharp that risks puncturing the operator and makes it very difficult, if not impossible, for the operator to remove the stylet.In the past, i've had to sometimes try to find a hemostat or clamp to grab and pull the stylet out when this happened.I was consulted to place an ngt in this patient and was demonstrating to the team the difference between a weighted feeding tube and a non-weighted feeding tube.In demonstrating using one of these coviden weighted feeding tubes, i demonstrated how to pull the stylet out and the stylet cap popped off, leaving me unable to pull the stylet out.This is a risk to both operator and patient safety.

• 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: 15635734
• MDR Text Key: 302059757
• Report Number: 15635734
• 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: 09/30/2022

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: Health Professional
• Device Model Number: 8884711253
• Device Catalogue Number: 8884711253
• Device Lot Number: 2127803964
• 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: 09/30/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23360 DA
• Patient Sex: Male
• Patient Weight: 69 KG
• Patient Ethnicity: Hispanic