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

Model Number	8884721088E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the feeding tube had a tear in it, 15cm from the distal end (so still in the stomach).There was no patient harm reported.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the feeding tube had a tear in it, 15cm from the distal end (so still in the stomach).There was no patient harm reported.Additional information was received from the customer and stated that the tube was clogged by the drugs due to bad irrigation probably and the tube ballooned to 15 cm which allowed the use of the tube to continue.The tube was installed 2 weeks max in the patient.The tear was discovered during the removal of the feeding tube and the x-ray confirmed there was no residual of the tube inside of the patient.The patient did not suffer any sequelae due to the presence of a fissure/weakness of the tube at the level of 15 cm; however, the crack was not caused by non-optimal irrigation by all the staff.The patient is stable without a feeding tube.
Additional Manufacturer Narrative
Section b5 (describe event or problem) has been updated to include additional information.Section h6 evaluation codes (health impact code) has been updated.
Additional Manufacturer Narrative
The device was received for evaluation and during evaluation, the reported issue of occlusion was observed; however, occlusion was caused by the accumulation of dry residue in the tube and the reported issue of tear was observed.The device history record (dhr) for lot 2500600864 was reviewed and the parameters documented, and quality tests performed show that the lot was manufactured according to standards and there were no discrepancies noted that could be associated with the event reported.Based on the information provided, a definitive root cause could not be determined.A possible root cause is that the tube may have been occluded and had a tear during use.The instructions for use outline provide information on usage of the tube and how to avoid the type of issues observed on the returned device.This information will be used for tracking and trending purposes, and we will continue to monitor.

• 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: 22048265
• Report Number: 1423537-2025-00204
• Device Sequence Number: 18362890
• Product Code: KNT
• UDI-Device Identifier: 10884521582996
• UDI-Public: (01)10884521582996(17)291231(10)2500600864
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K833621
• 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): 07/08/2025

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 Model Number: 8884721088E
• Device Catalogue Number: 8884721088E
• Device Lot Number: 2500600864
• 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: 05/16/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 05/20/2025; 07/08/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown