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

Model Number	8884721252E
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	07/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion the results will be forwarded.
Event or Problem Description
The customer reported prior to inserting the ng tube, they flushed the tube with water.After the tube was in the correct place, inside the stomach/duodenum, they attempted to remove the wire.At this point, it was stuck and would not come out.When the radiologist tried again the purple cap on top of the wire popped off and the wire cut through his glove and lacerated his right thumb.The thumb was cleaned with alcohol and a band-aid was applied.An occ health visit may be required.
Additional Manufacturer Narrative
Section b5 updated to include additional information received.
Event or Problem Description
The customer reported prior to inserting the ng tube, they flushed the tube with water.After the tube was in the correct place, inside the stomach/duodenum, they attempted to remove the wire.At this point, it was stuck and would not come out.When the radiologist tried again the purple cap on top of the wire popped off and the wire cut through his glove and lacerated his right thumb.The thumb was cleaned with alcohol and a band-aid was applied.An occ health visit may be required.Per additional information provided by the reporter on 03nov2025, this incident occurred some time ago, but to the best of their recollection they applied a bandage to the radiologist's thumb and completed a hospital incident report.The radiologist subsequently scheduled an occupational health appointment, during which he was instructed to undergo bloodwork.That was the full extent of the care and follow up he received.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.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.A device was not returned for evaluation; therefore, the affected product could not be evaluated to confirm the reported failure mode.As such, a root cause could not be determined at this time.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: 23453285
• Report Number: 1423537-2025-00444
• Device Sequence Number: 15424988
• Product Code: KNT
• UDI-Device Identifier: 10884521583030
• UDI-Public: (01)10884521583030(17)281231(10)2401701064
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2025

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
• Operator of Device: Health Professional
• Device Model Number: 8884721252E
• Device Catalogue Number: 8884721252E
• Device Lot Number: 2401701064
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 11/04/2025; 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown