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

Model Number	8884720205
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional 510 k number: k932295.Additional product code: pif.An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the broken bladder caused internally leakage.Per customer, everything works normally until the "bladder" breaks, forcing them to get the nurse back to change the tube.The patient has a nurse who places them and changes them, and she is specialized in tube feed.Additional information was received from the customer and stated that "bladder breaks" refers to balloon splits/breaks.There was no harm reported.
Additional Manufacturer Narrative
One device was received for investigation.The device was inspected, and the reported condition was observed.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.During production, inspectors routinely examine a statistical sample both physically and visually.The affected component is produced by an external supplier; our assembly process consists only of a pick and place operation for this material.A supplier corrective action request has been sent to the supplier to further investigate and address the reported condition.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: 22292921
• Report Number: 1423537-2025-00260
• Device Sequence Number: 21063277
• Product Code: KNT
• UDI-Device Identifier: 10884521007291
• UDI-Public: (01)10884521007291(17)260101(10)2226411964
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 08/25/2025

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 Expiration Date: 01/01/2026
• Device Model Number: 8884720205
• Device Catalogue Number: 8884720205
• Device Lot Number: 2226411964
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown