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

Model Number	8884711006E
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a nurse on 5s placed an ng tube on a patient with lot 2506902464, ref 8884711006e, and was unable to remove the guidewire with several attempts.The nurse got another from the pou with the same lot number to see why or if it was just her.Same lot, same issue.So, she got another lot number and placed it and was able to remove the guidewire with ease.The guidewire is sticking on the sidewall.The guidewire has to be massaged to remove it.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion the results will be forwarded.
Additional Manufacturer Narrative
A device was not returned for evaluation; therefore, the affected product could not be evaluated to confirm the reported failure mode.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 which was manufactured on march 11, 2025, 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.All processes and controls were found to be followed correctly, including packaging and all inspections performed on the product.No conditions were found that could trigger the reported condition.Based on all available information, a 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, 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: 24687589
• Report Number: 1423537-2026-00083
• Device Sequence Number: 15879601
• Product Code: KNT
• UDI-Device Identifier: 10884521582903
• UDI-Public: (01)10884521582903(17)300228(10)2506902464
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K112511
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

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
• Device Model Number: 8884711006E
• Device Catalogue Number: 8884711006E
• Device Lot Number: 2506902464
• 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: 03/16/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown