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

Model Number 8884711253E

Patient Problem Insufficient Information (4580)

Event Date 12/11/2023

Event Type  malfunction  

Event Description

On [redacted date] the nasogastric tube was inserted.Placement was confirmed via x-ray.The inner stylet was not removed during placement.It was not noticed by the care team as needing to be removed until [redacted date].It was noted that the inner stylet is purple, which is the same color as the rest of the tube.It is suggested that the inner stylet be made a different color so it will alert staff that it needs to be removed.It was also suggested that a tag be placed on the inner stylet stating: "remove prior to use".As the product exists now, the inner stylet blends in with the rest of the device and appears it should remain in place if you are unfamiliar with the product.

• Brand Name: KANGAROO
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 18483569
• MDR Text Key: 332551558
• Report Number: 18483569
• 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: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8884711253E
• Device Catalogue Number: 8884711253E
• Device Lot Number: 2324101864
• 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: 12/20/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Race: White