MAUDE Adverse Event Report: Cardinal Health 200, LLC CARDINAL HEALTH; Tubes, Gastrointestinal (And Accessories)

Model Number	8884711006E
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Dehydration (1807); Hyponatremia (4494)
Date of Event	05/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported the patient was found to have a dobhoff feeding tube with the stylet still in place several days after placement which led to dehydration and hyponatremia.Per the customer, while the metal stylet is essential for placement of the tube, removal of the stylet is a challenge.The stylet plastic tip is the very same color as the ports on the feeding tube and can be difficult to differentiate easily for users.There are two ports, so inexperienced users may think the stylet is supposed to be there and use the smaller port, restricting the flow rate of feeds and fluids.Per additional information provided on july 21, 2026, the treatment for dehydration was iv fluids x 24hours.There was no treatment provided for the hyponatremia which resolved prior to discharge, monitoring only.The tube was in place for 5 days before the stylet was found to still be in the tube.The stylet was removed and the tube remained in place with placement confirmed by x-ray.

• 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 ; +1(508)618-3640
• MDR Report Key: 50000546
• Report Number: 1423537-2026-00241
• Device Sequence Number: 10613481
• Product Code: KNT
• UDI-Device Identifier: 10192253011258
• UDI-Public: (01)10192253011258
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K112511
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 8884711006E
• Device Catalogue Number: 8884711006E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Race: White