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

Model Number	8884721252
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the nasogastric tube ruptured near the bifurcation, requiring removal and a new insertion.A new insertion occurred in the opposite nostril without any resistance.Upon removing the ruptured tube, she observed that it was not completely removed and that the metal tip was not in a device, appearing to have "burst." when questioned about an attempt to unblock the tube, she stated that it did not occur during her shift and that the replacement was solely due to an external rupture.They advised contacting the primary care team to report the incident, request an x-ray to confirm the new tube insertion, and attempt to identify the "lost" tip.Dr.E, from clinical oncology, advises that she will request an evaluation and opinion from the abdominal surgery team.The patient remains comfortable with no signs of discomfort or agitation and is currently unattended.No other information is able to be obtained as the event was reported anonymously to anvisa in brazil.
Additional Manufacturer Narrative
A non-conformance review was conducted for lot: 2108902564 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.There were no devices returned for evaluation; therefore, the affected product could not be evaluated to confirm the reported failure.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, 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: 22723397
• Report Number: 1423537-2025-00303
• Device Sequence Number: 8344843
• Product Code: KNT
• UDI-Device Identifier: 10884521518919
• UDI-Public: (01)10884521518919(17)260228(10)2108902564
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K833621
• 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): 08/05/2025

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 Expiration Date: 02/28/2026
• Device Model Number: 8884721252
• Device Catalogue Number: 8884721252
• Device Lot Number: 2108902564
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 08/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown