MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC ARGYLE; CATHETER, UMBILICAL ARTERY

Model Number	8888160333
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
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 air/oxygen in the line.Additional information was received from the customer and stated that they did not observe any cracks, holes or breaks in the line.There was no harm reported.
Additional Manufacturer Narrative
Section d4 (model number and catalog number): originally reported as 8888160531 and should be 8888160333; (unique identifier (udi) #): originally reported as (b)(4) and should be (b)(4).Section d3 (manufacturer name): originally reported as cardinal health, inc.And should be cardinal health 200, llc.
Additional Manufacturer Narrative
The device history record (dhr) review could not be performed since no lot number was provided.A device was received for evaluation, and the reported condition was not observed.A definitive root cause could not be determined.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 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 23771353
• Report Number: 1423537-2025-00496
• Device Sequence Number: 16110051
• Product Code: FOS
• UDI-Device Identifier: 10192253040302
• UDI-Public: (01)10192253040302
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K941814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2026

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
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 12/18/2025; 01/16/2026
• 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