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

Model Number	8884710859E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the patient had a weighted stylet 8 french nasogastric tube (ngt) placed and confirmed by chest x-ray (cxr).When changing the nose securement, it was noticed that the external length tick mark at the nare had a discrepancy of 8cm.Placement length was 57cm, previous shifts had documented 60cm, but nurse confirmed length of 65cm.Imaging was completed, showing that the weighted tip and tubing had become disconnected.The nurse was advised to retract the ngt by 5cm (from 65cm to 60cm) and then do a repeat kidney, ureter, and bladder (kub).The 2nd kub confirmed that the weighted tip and tubing had indeed come apart, and the weighted tip was floating freely in the stomach.It was expected that the patient would pass the tip.
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 a weighted stylet 8 french nasogastric tube (ngt) placed and confirmed by chest x-ray (cxr).When changing the nose securement, it was noticed that the external length tick mark at the nare had a discrepancy of 8cm.Placement length was 57cm, previous shifts had documented 60cm, but nurse confirmed length of 65cm.Imaging was completed, showing that the weighted tip and tubing had become disconnected.The nurse was advised to retract the ngt by 5cm (from 65cm to 60cm) and then do a repeat kidney, ureter, and bladder (kub).The 2nd kub confirmed that the weighted tip and tubing had indeed come apart, and the weighted tip was floating freely in the stomach.It was expected that the patient would pass the tip.Per additional information provided by the reporter on 23jan2025, the device was replaced with a new one.The patient was expected to pass the tip, but passed away due to his critical underlying illness; the device retention was not related to the patient's death or worsening of his condition.
Additional Manufacturer Narrative
The device history record (dhr) could not be reviewed as no lot information was provided within the complaint.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 samples returned for evaluation; therefore, the affected device could not be evaluated to confirm the reported failure mode.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: 21208446
• Report Number: 1423537-2025-00045
• Device Sequence Number: 18160523
• Product Code: KNT
• UDI-Device Identifier: 10884521582880
• UDI-Public: (01)10884521582880
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K112511
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2025

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: 8884710859E
• Device Catalogue Number: 8884710859E
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 01/24/2025; 02/24/2025
• 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: Male