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

Model Number	8884720247
Medical Device Problem Codes	Break (1069); Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported they received a call from the person in charge stating that the probe had burst and was leaking.It was then replaced with a temporary probe.
Additional Manufacturer Narrative
Additional product code: pif, additional 510k number: k180622.An investigation is currently underway.Upon completion the results will be forwarded.
Event or Problem Description
The customer reported they received a call from the person in charge stating that the probe had burst and was leaking.It was then replaced with a temporary probe.Per additional information provided, the leak started through the pipe, and after that, the balloon burst.
Additional Manufacturer Narrative
A device was not received for investigation, but a photo was provided.The photo was evaluated and the reported condition was observed.The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the observed condition.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Additionally, no nonconformances were opened during the manufacturing process.The investigation was conducted with the interdisciplinary team.All processes were reviewed and verified to be functioning correctly.No abnormal conditions were found that could trigger the reported condition.A supplier corrective action request has been sent to the supplier to conduct a more in-depth investigation related to this type of failure.¿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 200, LLC; 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: 24203389
• Report Number: 1423537-2026-00022
• Device Sequence Number: 15838791
• Product Code: KNT
• UDI-Device Identifier: 10192253011562
• UDI-Public: (01)10192253011562(17)270301(10)2401208764
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K180622
• 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): 03/13/2026

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: 8884720247
• Device Catalogue Number: 8884720247
• Device Lot Number: 2401208764
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 02/11/2026; 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown