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

Model Number	8884720858E
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient self-removed duo tube and about 8.5cm of tubing remained in the patient's stomach.Patient required egd [esophagogastroduodenoscopy] to remove remaining part.End of tube found to be frayed.Manufacturer response for tubes, gastrointestinal (and accessories), kangaroo (per site reporter).Asked for item to be returned to investigate further.

• Brand Name: KANGAROO
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 23827679
• Report Number: 23827679
• Device Sequence Number: 14725881
• Product Code: KNT
• UDI-Device Identifier: 10884521582972
• UDI-Public: (01)10884521582972
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/24/2025
• Report Date (Section F): 11/24/2025

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
• Device Model Number: 8884720858E
• Device Catalogue Number: 8884720858E
• Device Lot Number: 2513505964
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/17/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Female
• Date Report Sent to FDA: 11/24/2025