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

Model Number	8884711253E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported on february 13, 2025, shift chief performs sny passage by medical order, which is located in the right nostril, performs procedure without complications.On (b)(6) 2025 the nutrition step begins at 10cc/hour; however, nutrition pump indicates that there is an occlusion and does not allow the passage of food.Shift leader proceeds to irrigate the nasojejunal tube, which is met with resistance, finally decides to advance new tube through the left nostril and when removing the previous one he observes that it is fractured, a medical device report is made.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion the results will be forwarded.
Additional Manufacturer Narrative
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.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 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: 21584891
• Report Number: 1423537-2025-00125
• Device Sequence Number: 12978880
• Product Code: KNT
• UDI-Device Identifier: 10884521582927
• UDI-Public: (01)10884521582927(17)290831(10)2425601364
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K112511
• 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
• Report Date (Section B): 03/19/2025

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: 8884711253E
• Device Catalogue Number: 8884711253E
• Device Lot Number: 2425601364
• 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: 03/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male