MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884702500
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
When opening new, out of package, gravity feeding bag- noted there was no roller clamp.Unable to regulate speed of formula delivery.

• Brand Name: KANGAROO
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 24114871
• Report Number: 24114871
• Device Sequence Number: 9689800
• Product Code: KNT
• UDI-Device Identifier: 10192253011104
• UDI-Public: (01)10192253011104
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2025
• Report Date (Section F): 12/15/2025

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
• Operator of Device: Health Professional
• Device Model Number: 8884702500
• Device Catalogue Number: 8884702500
• Device Lot Number: 2508300194
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/20/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/15/2025