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

Model Number	8884720221
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code: pif.Additional 510k number: k932295.An investigation is currently underway.Upon completion the results will be forwarded.
Event or Problem Description
The customer reported they have recently observed an increased incidence of balloon rupture resulting in tube dislodgement.Per additional information provided on 13mar2026, an incidence of a balloon rupture occurred on (b)(6) 2025 at 1300hr.The g-tube was found dislodged with the balloon ruptured, and was replaced with another g-tube, item code: 8884720221e, not 8884720221.
Additional Manufacturer Narrative
The device was not received for investigation as per the customer it was discarded but a photo was provided.The photo was evaluated and the reported condition was observed.The device history record could not be reviewed as no lot information was provided within the complaint.However, it is important to note, 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.To further investigate the reported condition, a gemba on-site inspection of the manufacturing process was conducted.All processes were reviewed and their correct operation was verified.No abnormal conditions were found that could continue to trigger the reported condition.A supplier corrective action request was generated and sent to the supplier for further analysis of the reported condition.Additionally, appropriate internal personnel have been notified of this complaint for awareness.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: 24610970
• Report Number: 1423537-2026-00071
• Device Sequence Number: 9834071
• Product Code: KNT
• UDI-Device Identifier: 10192253011548
• UDI-Public: (01)10192253011548
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K180622
• 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): 04/21/2026

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: 8884720221
• Device Catalogue Number: 8884720221
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/21/2026
• 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