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

Model Number	8888160531
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the catheter was inserted on (b)(6) 2025 in the morning at the obstetric center, and on (b)(6) 2025 at night it was observed that it leaked when injected into the primary lumen.The newborn was in a minimum handling protocol, requiring manipulation.During the investigation, it was verified that there was a leak in the catheter extension when one of the routes was used.Due to the leak, two (02) days after insertion, the catheter was removed and a picc was necessary.Per customer, the umbilical catheter usually remains in place for up to seven (07) days for planning another venous access; there was no patient harm reported.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) for lot 2320700127 was reviewed and no anomalies related to the reported issue were observed.There were no samples returned for evaluation; however, a video was provided for analysis.Upon inspection, the catheter showed signs of use, and the catheter had a leak in the tube.Based on the information provided, it was determined that the most probable cause of the reported issue is that the catheter was damaged during use.The instructions for use outline the correct way to use the catheter and how to avoid the type of damage observed on the device.Per instruction of use, catheter should not be pinched or bent back to temporarily occlude the catheter, since it increases stress on the catheter or pigtail which can lead to a leak or break.Based on this information, no corrective actions are warranted at this time.This information will be used for tracking and trending purposes, and we will continue to monitor.

• 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; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 22475265
• Report Number: 1423537-2025-00281
• Device Sequence Number: 8016257
• Product Code: FOS
• UDI-Device Identifier: 20884527005175
• UDI-Public: (01)20884527005175(17)280630(10)2320700127
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K941814
• 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): 09/10/2025

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: 8888160531
• Device Catalogue Number: 8888160531
• Device Lot Number: 2320700127
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 09/11/2025
• 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