MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC KANGAROO; TUBE, FEEDING

Catalog Number HP110658

Device Problems Leak/Splash (1354); Air/Gas in Device (4062)

Patient Problem Insufficient Information (4580)

Event Date 01/25/2023

Event Type  malfunction  

Event Description

This rn went into the room to check on the patient.Patient is on continuous feeds via j-tube, infusing at 75 ml/hr.This rn was going to refill bag when she noticed that there was an air pocket in the tubing that was above cartridge and about 8" below cartridge.Rn discovered that the formula was leaking out of the tube onto the floor.No air appeared to have been infused into the patient as there was formula present in the distal tube attached to the patient.

• Brand Name: KANGAROO
• Type of Device: TUBE, FEEDING
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 16371354
• MDR Text Key: 309492352
• Report Number: 16371354
• Device Sequence Number: 1
• Product Code: FPD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: HP110658
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/27/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female