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

Model Number	461055E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code: (b)(4).Additional 510k number: k123555.An investigation is currently underway.Upon completion the results will be forwarded.
Event or Problem Description
The customer reported a tear in the inserted portion of the ng tube which was noted when the tube was removed.

• Brand Name: KANGAROO
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 25209134
• Report Number: 1423537-2026-00161
• Device Sequence Number: 15694183
• Product Code: KNT
• UDI-Device Identifier: 10192253007855
• UDI-Public: (01)10192253007855
• Combination Product (Y/N): N
• PMA/510(K) Number: K163002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2026

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: 461055E
• Device Catalogue Number: 461055E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 07/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male