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

Model Number	8888160333
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
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 lur-lock end of umbilical arterial catheter (uac) would not screw tight to transducer end (spinning in continuous circle without locking).The customer tried another transducer and same problem occurred.The customer further stated that they attached anesthesia extension tubing to uac on one end and the other to transducer.There was no harm reported.
Additional Manufacturer Narrative
The device history record (dhr) for lot 2430300084 was reviewed and no anomalies related to the reported issue were observed.There were no photos or physical samples received for evaluation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.However, based on the previous events reported, a corrective and preventative action has been opened to address the reported issue.We will continue to monitor related reports to determine if additional actions are necessary.

• 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: 21724827
• Report Number: 1423537-2025-00144
• Device Sequence Number: 11714400
• Product Code: FOS
• UDI-Device Identifier: 10192253040302
• UDI-Public: (01)10192253040302(17)290929(10)2430300084
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025

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: 8888160333
• Device Catalogue Number: 8888160333
• Device Lot Number: 2430300084
• 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: 03/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 04/25/2025
• 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