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

Model Number	8884721088E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion the results will be forwarded.
Event or Problem Description
The customer reported the distal weighted end of a duo tube was left in a patient after the tube broke while removing it.Per additional information provided, the weighted tip was removed with the help of the gi lab on (b)(6) 2026 at 1300 via esophagogastroduodenoscopy (egd) with biopsy.To the customer's knowledge, there have been no associated signs, symptoms, injuries, or complications related to this event.

• 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: 50808394
• Report Number: 1423537-2026-00293
• Device Sequence Number: 20981700
• Product Code: KNT
• UDI-Device Identifier: 10192253011753
• UDI-Public: (01)10192253011753
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K833621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 8884721088E
• Device Catalogue Number: 8884721088E
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/17/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown