MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC KANGAROO; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	461420E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
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 the nurse went to adjust the tape and the ng tube snapped in half.The tube had to be replaced.Per additional information provided on (b)(6) 2026, the ng feeding tube was removed by hand and replaced with a new ng tube.No special procedure needed to be performed.
Additional Manufacturer Narrative
One device was received for investigation.A visual technical evaluation was performed and the reported condition was 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 criteria and was released.A gemba inspection was performed to review the manufacturing process.All processes were reviewed and verified to be functioning correctly.No abnormal conditions were found that could continue to trigger the reported condition.A detailed analysis of the fracture area indicates that the geometry of the cut presents characteristics highly consistent with damage induced by a sharp object, as evidenced by the cut edge.In order to determine a possible relationship with the manufacturing process, replication tests were performed under controlled conditions using equivalent product, without being able to reproduce the same failure mode.Based on all available information, a definitive root cause could not be determined at this time.The available technical evidence does not support a cause related to the manufacturing process, and the characteristics of the damage suggest a possible external factor occurring after production.The complaint has been communicated to relevant personnel for awareness purposes.No further corrective or preventive actions are required as no nonconformities were identified in the product or the process.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: KANGAROO
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• 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: 25003920
• Report Number: 1423537-2026-00116
• Device Sequence Number: 21018099
• Product Code: PIF
• UDI-Device Identifier: 10192253007992
• UDI-Public: (01)10192253007992(17)300731(10)2523301464
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K150084
• 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): 05/20/2026

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: 461420E
• Device Catalogue Number: 461420E
• Device Lot Number: 2523301464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown