MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721088E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the kendall entriflex nasogastric feeding tube size 10 french x 43 inches became un-intact while inserted in the gastric tract.The tube appeared to have expanded causing it to rupture and become detached from the proximal portion of the tube.Proximal portion of the tube was removed from the patient but approximately 30 centimeters of the distal portion remains inside the gastric tract.Per additional information provided on 08-apr-2026, to resolve the issue, another feeding tube was placed.The foreign body was never removed from the patient as they passed away from acuity of illness, not related to the feeding tube.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion the results will be forwarded.
Additional Manufacturer Narrative
The device history record could not be reviewed as no lot information was provided within the complaint.However, 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.The device was not returned for evaluation; therefore, the affected product could not be evaluated to confirm the reported failure mode.A gemba on-site inspection of the manufacturing process was carried out.All processes were reviewed and their correct operation was verified.No abnormal conditions were found that could continue to trigger the reported condition.Based on all available information and given that no samples or images were available for technical evaluation, a root cause cannot be determined at this time.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: CARDINAL HEALTH
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 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: 24816937
• Report Number: 1423537-2026-00105
• Device Sequence Number: 20336489
• Product Code: KNT
• UDI-Device Identifier: 10192253011753
• UDI-Public: (01)10192253011753
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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
• Device Model Number: 8884721088E
• Device Catalogue Number: 8884721088E
• 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: 04/02/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 05/13/2026
• 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 Age: 37 YR
• Patient Sex: Male
• Patient Weight: 69 KG
• Patient Race: Black Or African American