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

Model Number	8884720858E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the dobhoff tip ng tube broke into two pieces while indwelling in the patient.A portion of the feeding tube was retained within the patient.The break of the tube occurred at the area of 5.6-8cm on the tube.The tube was indwelling for 2 days before break.The remaining portion of tube was removed endoscopically.Feed history: jevity 1.5 cal.Water history: 11/13 30 ml q4h: 1522, 1742, 2059, 11/14 50 ml q4h: 0128, 0550, 0930, 1302, 1706, 2108, 11/15 100 ml q4h: 0130, 0520, 0913, 1316, 1811, 2200.Medication history: amiodarone, aspirin, lipitor, lisinopril, lopressor, multivitamin, oxycodone, gylcolax, senakot-s, brilinta, trazadone, potassium chloride.Supplement history: prosource 60 ml tid, banatrol 60 ml bid.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion the results will be forwarded.
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.The lot met all defined criteria and was released.A device was not returned for evaluation; therefore, the affected product could not be evaluated to confirm the reported failure mode.As part of the investigation, a gemba walk was held in the production area and it was concluded that the current manufacturing activities are running according to product specifications meeting quality acceptance criteria, validation process, and released procedures.All processes and controls were found to be followed correctly, including packaging and all inspections carried out on the product.No conditions were found that could trigger the reported condition.Based on all available information, a definitive 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: 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: 25126773
• Report Number: 1423537-2026-00150
• Device Sequence Number: 18301296
• Product Code: KNT
• UDI-Device Identifier: 10192253011715
• UDI-Public: (01)10192253011715(17)300430(10)2514610764
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K833621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884720858E
• Device Catalogue Number: 8884720858E
• Device Lot Number: 2514610764
• 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: 05/06/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown