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

Model Number	461243E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported while removing the tube from the patient they observed that the tip had partially disintegrated.Upon comparing it with a new, unused device, it was clear that the original convex dome of the tip had been "eaten away." a portion of the tip is missing.Additional information received: the patient had no procedures to locate the missing piece of the tube.The patient did not require any medications due to the missing piece of the tube.The tube was placed on (b)(6) 2024, and removed on (b)(6) 2024.Nutrition used was pivot, up to 85 ml/hr for the duration of the tube in place.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.Additional 510k number k123555.
Additional Manufacturer Narrative
The device history record (dhr) could not be reviewed as the serial number was not provided within the complaint.
Additional Manufacturer Narrative
The device history record (dhr) could not be reviewed as the serial number was provided within the complaint.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 physically evaluated.However, photos were provided.The photos were inspected, and the reported condition was confirmed.Based on all available information, a definitive root cause could not be determined.However, it is important to note that based on the provided information, the tube had been in the patient for more than 50 days which is beyond the recommended 28 days noted in the instructions for use (ifu).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 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 21035626
• Report Number: 1423537-2024-00359
• Device Sequence Number: 8594707
• Product Code: KNT
• UDI-Device Identifier: 10192253007916
• UDI-Public: (01)10192253007916
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K163002
• 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,Followup
• Report Date (Section B): 01/13/2025

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: 461243E
• Device Catalogue Number: 461243E
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 01/13/2025; 01/13/2025
• 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