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

Model Number	8884721252E
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2026
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 that occurs quite frequently is that after the tube is positioned in the stomach, it can be extremely difficult to withdraw the wire (stylet).When force is applied, the purple cap may detach, exposing the hooked wire underneath.This creates a safety risk, as the exposed wire can cause cuts if not handled carefully, an incident that has already affected two of their radiologists.As a result, one radiologist now refuses to pull on the cap altogether.Instead, they have to use a kelly clamp to remove the wire when it becomes stuck, even after flushing the tube with water beforehand to help loosen it.The wire was tested prior to use by pulling it in and out of the tube.In this instance the stylet was eventually removed by pulling very hard and using a kelly clamp.There was no patient injury or medical intervention.Per further information provided on (b)(6) 2026, the purple cap did detach during this incident.However, radiologists were not harmed during this event.The mention of two radiologist who have been affected are referring to prior incidents.The hydromer coating on the inner diameter of the tube was activated by injecting approximately 10 ml of water prior to patient insertion and was reactivated with 10ml of water after placement.

• 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: 25398467
• Report Number: 1423537-2026-00179
• Device Sequence Number: 10718845
• Product Code: KNT
• UDI-Device Identifier: 10192253011838
• UDI-Public: (01)10192253011838(17)310131(10)2605701064
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K833621
• 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): 07/08/2026

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: 8884721252E
• Device Catalogue Number: 8884721252E
• Device Lot Number: 2605701064
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2026
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown