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

Model Number	461055E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Gastrointestinal Regurgitation (4477)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that dobhoff tube ruptured longitudinally approximate 2 cm in length.Enteral feeds were refluxing out of the patient's left nare.Per customer, the tube was removed and replaced.Additional information was received and stated that there was no medical intervention or treatment provided.The patient is doing ok.
Additional Manufacturer Narrative
510(k)numbers: k163002 and k12355.A device history record review could not be performed because the serial number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.One physical sample was received by cardinal health but only a photo was provided to the supplier per their request.Per the supplier, the provided photo was reviewed, and the reported condition was confirmed.Based on all available information, the root cause could not be determined.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to current quality standards and inspection procedures.All information received will be used for further tracking and trending purposes.

• 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; 3651 birchwood drive; waukegan IL 60085
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 20464464
• Report Number: 1423537-2024-00244
• Device Sequence Number: 7718172
• Product Code: KNT
• UDI-Device Identifier: 10192253007855
• UDI-Public: (01)10192253007855
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H10
• 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
• Report Date (Section B): 10/16/2024

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: 461055E
• Device Catalogue Number: 461055E
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 10/16/2024
• 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