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

Model Number	8884711253E
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
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 four separate feeding tubes kinked above the weighted tip and they were unable to unkink or flush.This was attempted under endoscopic guidance.Physician also reported the stylet is stiff/stuck and difficult to mobilize.Per additional information provided by the customer on (b)(6) 2026, all four devices were used with the same patient.The facility inserts these tubes in endoscopy at the request of the physician to ensure adequate placement.It was confirmed that prior to placement 10ml of water was injected into the tubes and the weight assemblies were submerged in water for at least 5 seconds to activate the hydromer coating and once the tube position was confirmed, the hydromer coating was reactivated with another 10ml of water before attempting to remove the stylet.The issue wasn¿t resolved until they found a tube that didn¿t kink.The affected tubes were removed and discarded.

• 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: 25117029
• Report Number: 1423537-2026-00147
• Device Sequence Number: 10346945
• Product Code: KNT
• UDI-Device Identifier: 10192253011296
• UDI-Public: (01)10192253011296
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112511
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2026

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
• Operator of Device: Health Professional
• Device Model Number: 8884711253E
• Device Catalogue Number: 8884711253E
• 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: 05/04/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 06/11/2026
• 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