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

Model Number	8884720858E
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that patient's dobhoff was pulled to prepare for magnetic resonance imaging (mri) and was found to have a frayed end with a missing weighted end.Per customer, kidney, ureter, and bladder (kub) confirmed that there was a weighted end in the patient's stomach along with a portion of the tubing.Note: several attempts to gather information from the customer were made.To date, no response has been received.If additional pertinent information becomes available, the report will be updated.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Section b5 has been updated to include additional information.
Event or Problem Description
The customer reported that patient's dobhoff was pulled to prepare for magnetic resonance imaging (mri) and was found to have a frayed end with a missing weighted end.Per customer, kidney, ureter, and bladder (kub) confirmed that there was a weighted end in the patient's stomach along with a portion of the tubing.Additional information was received from the customer and stated that the weighted end was not removed.The last kub showed that the weighted end (approximately 10.7 cm in length) was over the right lower quadrant of the abdomen.The patient was discharged and the customer further stated that they do not know what the outcome of the weighted end was, as the patient is no longer in their services.The patient was discharged with home health services.
Additional Manufacturer Narrative
The device history record (dhr) for lot number 2330600564 was reviewed and no anomalies related to the reported issue were observed.There was no sample returned for evaluation; therefore, the affected device could not be evaluated to confirm the reported issue.As such, a root cause could not be determined at this time.However, a corrective and preventative action has been opened to address the reported issue.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: 22150652
• Report Number: 1423537-2025-00223
• Device Sequence Number: 8347748
• Product Code: KNT
• UDI-Device Identifier: 10884521582972
• UDI-Public: (01)10884521582972(17)281031(10)2330600564
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K833621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2025

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 Model Number: 8884720858E
• Device Catalogue Number: 8884720858E
• Device Lot Number: 2330600564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 06/12/2025; 06/20/2025
• 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