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

Model Number	8884720247
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the patient lost her kangaroo 24 fr gtt (gastrostomy feeding tube), which was inflated with 15 ml of ad (distilled water) on (b)(6) 2024, due to a rupture of the cuff.Since this is a patient diagnosed with alzheimer's, dm, recurrent utis and is bedridden, she is under home care with 12 hours of daytime nursing and at night with the caregiver.She has limited movement, for this reason she does not pull the gtt.The technicians and caregivers are completely cautious, capable and experienced in handling, administering medications, diet and liquids through this device.The device had to be changed by a professional due to the ruptured cuff.
Additional Manufacturer Narrative
Additional 510k number: k932295.Additional product code: pif.An investigation is currently underway.Upon completion the results will be forwarded.
Additional Manufacturer Narrative
A non-conformance review was conducted for the reported lot (2400121964) and there were no ncs related to the reported event issued during the manufacturing of this lot.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.A device was not returned for evaluation; therefore, the affected product could not be evaluated to confirm the reported failure mode.As such, a root cause could not be determined.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: 21919062
• Report Number: 1423537-2025-00184
• Device Sequence Number: 8651013
• Product Code: KNT
• UDI-Device Identifier: 10192253011562
• UDI-Public: (01)10192253011562(17)270301(10)2400121964
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 08/18/2025

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: 8884720247
• Device Catalogue Number: 8884720247
• Device Lot Number: 2400121964
• 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: 04/21/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/02/2025; 08/18/2025
• 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: Female