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	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: the device developed leaks and was externalized on the patient.The nurse reported that the installation of the device followed all recommendations for use.Per additional information received on (b)(6) 2024, the leak occurred at the inflation balloon and was replaced.The patient did not required medical intervention and the device was replaced.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A sample was not received for the investigation.Because a sample was not returned, we were unable to perform functional and visual evaluations to confirm the reported condition and determine the root cause.A supplier corrective action request has been sent to the supplier of the reported affected component to further investigate and address the reported condition.All information received will be used for tracking and trending purposes.Section h6 component code corrected from 4733: connector/coupler to 419: balloon.

• 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 INC.; 3651 birchwood drive; waukegan IL
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 20359113
• Report Number: 1423537-2024-00179
• Device Sequence Number: 12777214
• Product Code: KNT
• UDI-Device Identifier: 10884521007291
• UDI-Public: (01)10884521007291(17)260601(10)2315311564
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K932295
• 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): 10/21/2024

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: 06/01/2026
• Device Model Number: 8884720205
• Device Catalogue Number: 8884720205
• Device Lot Number: 2315311564
• 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: 09/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown