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

Model Number	8884721088E
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the patient had an ng tube inserted and after the x-ray, one of nurses trying to take the wire out noted it was a faulty ng tube.The patient had the ng tube inserted by a senior rn colleague from another area with experience of ngt insertion in patients with eating disorders.X-ray attended and was deemed placed suitably for use.After the x-ray, the patient and mum requested to remove the wire.A few rns tried to take the wire out but it was not successful.Ngt was eventually removed following a code black on patient and her mother.A senior nurse from met team went to help and he found the ng tube was faulty so he took out whole tube.The treating team was informed.A new ngt was inserted overnight as patient is on an ed3.Per additional information provided, the hydromer coating on the inner diameter of the tube was activated by injecting approximately 10 ml or water prior to insertion and was reactivated with 10ml of water after placement per the ifu.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion the results will be forwarded.
Event or Problem Description
The customer reported the patient had an ng tube inserted and after the x-ray, one of nurses trying to take the wire out noted it was a faulty ng tube.The patient had the ng tube inserted by a senior rn colleague from another area with experience of ngt insertion in patients with eating disorders.X-ray attended and was deemed placed suitably for use.After the x-ray, the patient and mum requested to remove the wire.A few rns tried to take the wire out but it was not successful.Ngt was eventually removed following a code black on patient and her mother.A senior nurse from met team went to help and he found the ng tube was faulty so he took out whole tube.The treating team was informed.A new ngt was inserted overnight as patient is on an ed3.

• 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: 24801108
• Report Number: 1423537-2026-00100
• Device Sequence Number: 10666625
• Product Code: KNT
• UDI-Device Identifier: 10884521582996
• UDI-Public: (01)10884521582996(17)280731(10)2322705664
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/18/2026

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: 8884721088E
• Device Catalogue Number: 8884721088E
• Device Lot Number: 2322705664
• 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: 03/24/2026
• Supplement Date Received by Manufacturer: Not provided; 04/06/2026; Not provided
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 04/08/2026; 04/13/2026; 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown