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

Model Number	8884721088E
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion the results will be forwarded.
Event or Problem Description
The customer reported they were unable to remove the guidewires (stylets).Sterile water was flushed into the tubes but they were still unable to remove the guidewires (stylets).The ngts were sourced from icu.Per additional information provided on 26mar2026, the tubes were injected with 10ml h2o.The tubes were not used with a patient, the issue occurred when the tubes were tested before insertion.The issue was resolved by using an ng tube from another manufacturer.
Additional Manufacturer Narrative
Seven samples were received for investigation.The samples were visually and functionally evaluated, and the reported condition was not observed.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.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.The lot met all defined acceptance requirements and was released.A gemba walk was held in the production area; as a result, it was concluded that the current manufacturing activities are running according to product specifications meeting quality acceptance criteria, validation process, and released procedures.No conditions were found that could trigger the reported condition.Based on all available information, a definitive root cause could not be determined at this time.The potential root cause indicates that this problem could occur due to improper use of the procedure if the instructions for use are not followed.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: 24709364
• Report Number: 1423537-2026-00085
• Device Sequence Number: 5763269
• Product Code: KNT
• UDI-Device Identifier: 10884521582996
• UDI-Public: (01)10884521582996(17)280731(10)2322705664
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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: 8884721088E
• Device Catalogue Number: 8884721088E
• Device Lot Number: 2322705664
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown