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

Model Number	460711E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One physical sample with lot number 2301026064 was received for investigation.A visual inspection was performed, and the reported condition was confirmed.A root cause analysis indicated that this issue occurred as a result of the tubing being trapped during the sealing process.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Corrective and preventative actions have been implemented to address the reported condition.All information received will be used for further tracking and trending purposes.
Event or Problem Description
The customer reported the product was obtained from the clean supply room on (b)(6) and inserted.On (b)(6) the nurse was checking the placement and didn't hear a "pop" sound, so she pulled the tube out and noticed it ends at 8cm.She did rl and reported it to the neonatologist.An x-ray was done and nothing was found.There was no patient injury.

• 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 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 20402003
• Report Number: 1423537-2024-00204
• Device Sequence Number: 16982123
• Product Code: PIF
• UDI-Device Identifier: 10884521547216
• UDI-Public: (01)10884521547216(17)271231(10)2301026064
• 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): 10/09/2024

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
• Operator of Device: Health Professional
• Device Model Number: 460711E
• Device Catalogue Number: 460711E
• Device Lot Number: 2301026064
• 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: 10/14/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown