MAUDE Adverse Event Report: CARDINAL HEALTH, INC. ARGYLE; CATHETER, UMBILICAL ARTERY

Model Number	8888160341
Medical Device Problem Codes	Fluid/Blood Leak (1250); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) for lot number 2425600065 was reviewed and no anomalies related to the reported issue were observed.The device was received for evaluation and reported issue of leaking was not observed; however, the reported condition of cannot connect to hub was observed.A corrective and preventive action has been initiated to further investigate this issue.
Event or Problem Description
The customer reported that in the process of removing air, sampling ports " flicked" and fluid noticed to come out.They attempted to secure sampling port, it spun, no securing snugly/ but not coming off.There was no harm reported.Additional information was received from the customer and stated that when the nurse said that the product was ¿flicked¿, they're referring to how they "flick¿ their lines to help move air out of them.So the nurse saw air in the line and then flicked it with their fingers to move the air up to a port so it can be withdrawn, but when they did that action, fluid came out/off of the line.There was no crack or break in the sampling port or line.The nurses noted the sampling port wasn't on securely and when they tried to tighten it, it just spun on the threads and wouldn't lock.When they tried to attach another sampling port the same thing happened.Nothing would secure to the umbilical line, so they had to remove it.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.

• Brand Name: ARGYLE
• Common Device Name: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH, INC.; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 21950612
• Report Number: 1423537-2025-00189
• Device Sequence Number: 8720468
• Product Code: FOS
• UDI-Device Identifier: 10192253040319
• UDI-Public: (01)10192253040319(17)290813(10)2425600065
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K130725
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

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: 8888160341
• Device Catalogue Number: 8888160341
• Device Lot Number: 2425600065
• 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: 04/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown