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

Model Number	8888160341
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
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 that the item presented memory and extravasation.
Additional Manufacturer Narrative
A non-conformance review was conducted for lot: 2318100195 and there were no ncs related to the reported event issued during the manufacturing of this lot.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.There were no devices returned for evaluation; therefore, the affected product(s) could not be evaluated to confirm the reported failure mode.As such, a root cause could not be determined.We are unable to associate this reported issue with an open capa due to no photo or sample received for evaluation.We will continue to monitor related reports to determine if additional actions are necessary.
Additional Manufacturer Narrative
The device history record (dhr) for lot number 2318100195 was reviewed and no anomalies related to the reported issue were observed.The device was received for evaluation and reported condition of leaking was not observed; however, the reported condition of memory issue was observed.Corrective and preventive action has been initiated to further investigate this issue.

• 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: 21876194
• Report Number: 1423537-2025-00170
• Device Sequence Number: 7899766
• Product Code: FOS
• UDI-Device Identifier: 20884527005120
• UDI-Public: (01)20884527005120(17)280620(10)2318100195
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K130725
• 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,Followup
• Report Date (Section B): 10/01/2025

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
• Device Model Number: 8888160341
• Device Catalogue Number: 8888160341
• Device Lot Number: 2318100195
• 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: 04/07/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 05/07/2025; 10/01/2025
• 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