MAUDE Adverse Event Report: CARDINAL HEALTH, INC. KANGAROO; TUBE, FEEDING

Lot Number 223110174

Device Problems Leak/Splash (1354); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 12/12/2022

Event Type  malfunction  

Event Description

Patient was due for a new feeding bag as it had been 24 hours since the last bag was hung.Tubing primed well, although i had noticed slight leaking at the purple clamp part on the right side of the tubing if it was bent.When i took the cap off of the end of the tubing, it leaked all over the floor and couch before i even hooked it up to the patient.I immediately discarded the tubing and requested a new bag.

• Brand Name: KANGAROO
• Type of Device: TUBE, FEEDING
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 16378120
• MDR Text Key: 309570115
• Report Number: 16378120
• 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: 02/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 223110174
• 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: 02/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1