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

Model Number	8884710859E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion the results will be forwarded.
Event or Problem Description
The customer reported when passing the 8 fr probe with a weighted tip, the guide wire was removed, and upon testing, it was evident that there were many small holes in the probe and that it was porous.The probe was changed three times, with the same finding.Porosity along the length of the probe.
Additional Manufacturer Narrative
The device history record was reviewed and showed that the manufacturing and inspection of the product was performed as per applicable procedures and validated process.All inspection results were carried out and were within acceptable criteria as per established sampling plan level quality procedures.Additionally, no non-conformances were opened during the manufacturing process.A gemba walk was performed to review the manufacturing process, and all processes and controls were found properly followed, including sub-assemblies, finished product assembly, packaging, and inspections performed to the product.No conditions were found that could trigger the reported condition.An attempt was made to reproduce the defect, and the tube could not be broken after several manipulations.Based on all available information, a definitive root cause could not be determined at this time.A potential root cause could be that when trying to manipulate the stylet within the tube several times, the stylet perforated the tube.A corrective action is not applicable at this time.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: KANGAROO
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 24807471
• Report Number: 1423537-2026-00103
• Device Sequence Number: 13431777
• Product Code: KNT
• UDI-Device Identifier: 10884521582880
• UDI-Public: (01)10884521582880(17)280630102320506664
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K112511
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2026

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: 8884710859E
• Device Catalogue Number: 8884710859E
• Device Lot Number: 2320506664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 05/08/2026; 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Sex: Female