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

Model Number	8884720858E
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion the results will be forwarded.
Event or Problem Description
The customer reported an issue with the nasogastric tubes.Several nurses have reported a problem when removing the guide wire after the tube has been inserted.They stated that they properly moistened the tube beforehand.The reporter stated they tested a tube themself, and the guide slides correctly after humidification.Per additional information provided on (b)(6) 2026, the issue the nurses were experiencing was that they were completely unable to remove the stylet.It was stated that they put water in the tube but the process used and quantity of water injected is not known.To resolve the issues, the feeding tube has been removed and replaced.No further information is available regarding specific incidents.
Additional Manufacturer Narrative
A device was not returned for evaluation; therefore, the affected product could not be evaluated to confirm the reported failure mode.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 gemba walk was held in the production area.As a result, it was concluded that the current manufacturing activities are running according to product specifications meeting quality acceptance criteria, validation process and released procedures.No abnormal 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: 25053389
• Report Number: 1423537-2026-00137
• Device Sequence Number: 10100913
• Product Code: KNT
• UDI-Device Identifier: 10192253011715
• UDI-Public: (01)10192253011715(17)300430(10)2514610664
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,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
• Device Model Number: 8884720858E
• Device Catalogue Number: 8884720858E
• Device Lot Number: 2514610664
• 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: 04/23/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 05/18/2026
• 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 Sex: Unknown