MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

Model Number	8888266130E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code: pif.An investigation is currently underway.Upon completion the results will be forwarded.
Event or Problem Description
The customer reported they were testing a new tube from their unit 19 stores cart and the arv broke at the blue part.There was no patient involvement.
Additional Manufacturer Narrative
One device was received for investigation.The device was evaluated, and the reported condition was confirmed; the anti-reflux valve was observed to be split in two parts and showed signs of stress on the conical portion of the valve.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.As part of the investigation all processes and controls were reviewed and found to be correctly followed.There were no abnormal conditions found that could trigger the reported condition.Based on all available information, a definitive root cause could not be determined at this time.A corrective and preventative action has been opened to further investigate and address the reported condition.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: CARDINAL HEALTH
• Common Device Name: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• 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: 23683661
• Report Number: 1423537-2025-00485
• Device Sequence Number: 9661803
• Product Code: FEG
• UDI-Device Identifier: 10192253012835
• UDI-Public: (01)10192253012835(17)290228(11)240305(10)2406510464
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K190923
• 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): 12/30/2025

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: 8888266130E
• Device Catalogue Number: 8888266130E
• Device Lot Number: 2406510464
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown