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

Model Number	8884721088E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported on removal of the nasogastric tube, 30cm of tubing was missing.Dissection/separation of the tube within the polyurethane tubing section.The fine bore nasogastric tube separated/broke in half.The connection end was removed, however the remainder of the distal end of the tube was not retrieved from the patient.
Additional Manufacturer Narrative
A device history record review could not be performed because a lot 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.There were no photos or physical samples received for investigation.Based on all available information, we were unable to confirm the reported condition or determine the root cause.Staff has been notified of the reported condition to raise awareness.If a sample or additional information is received at a later date, the investigation will be updated accordingly.All information received will be used for tracking and trending purposes.
Event or Problem Description
The customer reported on removal of the nasogastric tube, 30cm of tubing was missing.Dissection/separation of the tube within the polyurethane tubing section.The fine bore nasogastric tube separated/broke in half.The connection end was removed, however the remainder of the distal end of the tube was not retrieved from the patient.Per additional information provided on 26 nov 2024, imaging was performed and the retained tube was visible on x-ray.As of november 07th, the retained portion of the tube had not yet been removed from the patient and a new feeding tube had not been placed.As of december 02, 2024, no further updates are available at this time.

• Brand Name: KANGAROO
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 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: 20729491
• Report Number: 1423537-2024-00314
• Device Sequence Number: 18241526
• Product Code: KNT
• UDI-Device Identifier: 10884521582996
• UDI-Public: (01)10884521582996
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K833621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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: 8884721088E
• Device Catalogue Number: 8884721088E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 12/03/2024
• 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