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

Model Number	8884720221
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code: pif.Additional 510 k number: k932295.An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that a balloon test was performed and the balloon showed a small amount of return.There was no patient harm reported.
Additional Manufacturer Narrative
The device history record (dhr) for lot number 2233328464 was reviewed and no anomalies related to the reported issue were observed.There were no samples returned for evaluation; therefore, the affected device could not be evaluated to confirm the reported failure mode.As such, a root cause could not be determined.However, the reported 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.All information received will be used for tracking and trending purposes.

• 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: 22151453
• Report Number: 1423537-2025-00225
• Device Sequence Number: 15572713
• Product Code: KNT
• UDI-Device Identifier: 10884521661721
• UDI-Public: (01)10884521661721(17)251201(10)2233328464
• 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
• Report Date (Section B): 07/01/2025

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 Expiration Date: 12/01/2025
• Device Model Number: 8884720221
• Device Catalogue Number: 8884720221
• Device Lot Number: 2233328464
• 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: 05/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 07/01/2025
• 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 Sex: Unknown