MAUDE Adverse Event Report: CARDINAL HEALTH, INC. ARGYLE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	460711
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported they have a product complaint with 7 eaches of 460711 6.5fr argyle feeding tube lot number 2215833464.One of the products was sealed with part of the product cut off outside the package.With the other six, the tube was split in two pieces inside the package.Photos attached.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Two unused physical devices were received for investigation.The devices were inspected and a cut in the tubes were observed.The cuts were found to be caused by the tubes being trapped during the sealing of the products.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Based on all available information, a definitive root cause could not be determined at this time.However, actions have been implemented to address the reported condition.This complaint will be used for tracking and trending purposes.

• Brand Name: ARGYLE
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• 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 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 20305996
• Report Number: 1423537-2024-00170
• Device Sequence Number: 7745175
• Product Code: KNT
• UDI-Device Identifier: 10884521067349
• UDI-Public: (01)10884521067349(17)270531(10)2215833464
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K820441
• 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): 10/28/2024

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: 460711
• Device Catalogue Number: 460711
• Device Lot Number: 2215833464
• 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: 09/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown