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

Model Number	461438
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
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 opened a new case of product and two out of ten feeding tubes were found in two pieces still in the packaging.The tubes should be one single piece but are cut/separated somehow.
Additional Manufacturer Narrative
The device history record (dhr) for lot 2500128364 was reviewed and no anomalies related to the reported issue were observed.A picture was provided for analysis, and upon reviewing the picture, the reported issue was observed.A physical device was not returned for evaluation.A definitive root cause could not be determined.Based on this information, no corrective actions are warranted 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; 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: 21697415
• Report Number: 1423537-2025-00141
• Device Sequence Number: 9419851
• Product Code: KNT
• UDI-Device Identifier: 10192253008005
• UDI-Public: (01)10192253008005(17)291231(10)2500128364
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K820442
• 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): 05/29/2025

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: 461438
• Device Catalogue Number: 461438
• Device Lot Number: 2500128364
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 05/29/2025
• 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