MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	461043E
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code: pif additional 510k number: k123555.An investigation is currently underway.Upon completion the results will be forwarded.
Event or Problem Description
The customer reported concern regarding an occurrence where a patient in the surgical trauma unit was using a kangaroo iris feeding tube.The feeding tube was confirmed to be in the stomach, however, when the nursing team went to remove the feeding tube, it got stuck at the 15-20cm mark.To the reporter's knowledge, the patient had no contraindications for having a feeding tube or any abnormalities with the patient's anatomy.The patient was complaining from experiencing pain from the attempts at removal, which lead to a doctor having to cut the tube and manipulate/remove the tube his/herself.Per additional information provided by the customer, when they confirmed the feeding tube was in the stomach and went to remove the stylet, they couldn't get it to budge which is what resulted in them trying to replace this specific feeding tube with a new one which ultimately led them to having issues removing it from the patient.This feeding tube was causing very excruciating pain for the patient at roughly the 15-20cm mark which led the surgeon to cut the feeding tube and extract it in a unique way through the patient's mouth.It was at this time they noticed ta knot in the feeding tube.
Additional Manufacturer Narrative
One incomplete used device was received at the cardinal health decontamination lab for investigation.The device could not be forwarded to the manufacturing site for physical inspection due to current customs policies.However, images of the device were provided to the manufacturing site for visual evaluation.In addition, an x-ray image was provided by the customer for review.The images were evaluated, and the reported condition was observed.The device history record (dhr) could not be reviewed as no lot information was provided within the complaint.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.Based on all available information, no conditions were found in the manufacturing process that could trigger the observed condition.As such, a definitive root cause could not be determined at this time.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 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 23646153
• Report Number: 1423537-2025-00481
• Device Sequence Number: 17349754
• Product Code: KNT
• UDI-Device Identifier: 10192253007831
• UDI-Public: (01)10192253007831
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K163002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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 Model Number: 461043E
• Device Catalogue Number: 461043E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/30/2025
• 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