MAUDE Adverse Event Report: CARDINAL HEALTH, INC. ARGYLE; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	461206E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2026
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 they needed a feeding tube and when grabbing this feeding tube the writer noticed that the tip looked flat/pinched.After inspecting it further, it is not the length that it should be, the last few centimeters are not there.It is cut off at the 8 cm mark and flattened.The writer opened the package, attached an enfit syringe and tried to pass air through the tubing, no air or fluid can pass through the tube.

• Brand Name: ARGYLE
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana IL 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 25281937
• Report Number: 1423537-2026-00169
• Device Sequence Number: 10085566
• Product Code: PIF
• UDI-Device Identifier: 10884521547247
• UDI-Public: (01)10884521547247(17)290131(10)2403731264
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K150084
• 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): 07/09/2026

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
• Device Model Number: 461206E
• Device Catalogue Number: 461206E
• Device Lot Number: 2403731264
• 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: 05/25/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2024
• 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