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

Model Number	8884721252
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported in an attempt to install the 12fr enteral feeding tube in the patient, when removing the guide wire, the nurse showed that the guide wire had positioned the probe, requiring removal and a new attempt to pass it.When removing the probe, it was observed that the tip radiopaque part of the device detached, becoming lodged in the patient's lung.An imaging exam was performed to confirm positioning.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history records were reviewed and indicated that the products were released accomplishing all quality standards.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.We will continue to monitor related reports to determine if additional actions are necessary.
Event or Problem Description
The customer reported in an attempt to install the 12fr enteral feeding tube in the patient, when removing the guide wire, the nurse showed that the guide wire had positioned the probe, requiring removal and a new attempt to pass it.When removing the probe, it was observed that the tip radiopaque part of the device detached, becoming lodged in the patient's lung.An imaging exam was performed to confirm positioning.Per additional information provided by the customer on 10feb2025, the patient did not experience any signs, symptoms or conditions as a result of the tip becoming lodged in the lung at first.The tip was removed from the lung by a bronchoscopy carried out as soon as the detachment was identified.
Additional Manufacturer Narrative
Two unused sealed devices were received for investigation.The devices were inspected, and the reported condition was not observed.As such, a root cause could not be determined at this time.However, a corrective and preventative action has been opened to 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: 21114800
• Report Number: 1423537-2025-00024
• Device Sequence Number: 18326217
• Product Code: KNT
• UDI-Device Identifier: 10884521518919
• UDI-Public: (01)10884521518919(17)270430(10)2214502164
• Combination Product (Y/N): N
• PMA/510(K) Number: K833621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8884721252
• Device Catalogue Number: 8884721252
• Device Lot Number: 2214502164
• 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: 01/03/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 01/14/2025; 02/11/2025; 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown