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

Model Number	8884711253E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A non-conformance review was conducted for lot 2328307464 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.The complaint device was not returned for evaluation; therefore, the affected product could not be evaluated to confirm the reported issue.As such, a root cause could not be determined.We will continue to monitor related reports to determine if additional actions are necessary.
Event or Problem Description
The customer reported that after the nasoenteral tube was inserted, the weight of the tube came loose inside the patient, making it necessary to remove it by egd (esophagogastroduodenoscopy).No further information is able to be obtained as the event was reported anonymously to anvisa in brazil.

• 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: 22564421
• Report Number: 1423537-2025-00289
• Device Sequence Number: 9247611
• Product Code: KNT
• UDI-Device Identifier: 10884521582927
• UDI-Public: (01)10884521582927(17)280930(10)2328307464
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K112511
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884711253E
• Device Catalogue Number: 8884711253E
• Device Lot Number: 2328307464
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/22/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown