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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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 umbilical catheter was leaking.There was no difficulty in insertion.Per customer, they had to remove the central line because questionably septic infant lost all antibiotic that was given plus approximately 20 ml of iv fluid.
Event or Problem Description
The customer reported that the umbilical catheter was leaking.There was no difficulty in insertion.Per customer, they had to remove the central line because questionably septic infant lost all antibiotic that was given plus approximately 20 ml of iv fluid.Additional information was received from the customer and stated that the line needed to be removed, needed a peripheral iv start (which is a painful procedure) and patient missed doses of antibiotic.However, ultimately no other harm resulted from the incident.
Additional Manufacturer Narrative
Section b5 has been updated to include additional information.See section h6 evaluation codes (health effect - clinical code): updated to 4582 - no clinical signs, symptoms or conditions.
Additional Manufacturer Narrative
The device history record (dhr) for lot 2329900100 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.Based on this information, no corrective actions are warranted at this time.We will continue to track and trend through our monitoring programs and take actions as applicable.

• 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: 21267654
• Report Number: 1423537-2025-00057
• Device Sequence Number: 19712876
• Product Code: FOS
• UDI-Device Identifier: 20884527005120
• UDI-Public: (01)20884527005120(17)281012(10)2329900100
• 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,Followup
• Report Date (Section B): 02/24/2025

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: 2329900100
• 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: 01/16/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 02/04/2025; 02/24/2025
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown