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

Model Number	8888160556
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	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 vein catheter (uvc) was placed as they were unable to obtain peripheral intravenous (piv) access.The uvc was placed, and infant tolerated the procedure well.When the registered nurse (rn) went to hook up fluids to the uvc primary hub, the iv tubing would connect, but not screw on.It just kept turning and not screw on tightly.The rn tried to screw the iv fluids on to the secondary lumen hub and the iv fluids would also not screw on properly but were tighter than the primary lumen hub.Neonatal nurse practitioner (nnp) called to the bedside and the situation was explained.Nnp student who placed the uvc stated that he didn't notice any difficulty when screwing on a syringe to draw labs and verify uvc placement.Upon further investigation, it looked like there were "ridges" on the primary hub that prevented iv fluids from being tightened properly.It was decided that they would not use the primary hub, and it was taped off, so all other staff knew not to use.As for the secondary, a clave was placed to help make the connection tighter, and iv fluids were being ran through the secondary lumen.There was no patient harm reported.
Additional Manufacturer Narrative
The device history record (dhr) for lot 2404400070 was reviewed and no anomalies related to the reported issue were observed.A few pictures were provided for analysis, and the reported issue was not observed due to the low-quality images.A physical device was not returned for evaluation; therefore, the affected device could not be evaluated to confirm the reported issue.A root cause could not be determined at this time.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: 21654227
• Report Number: 1423537-2025-00132
• Device Sequence Number: 7480224
• Product Code: FOS
• UDI-Device Identifier: 20884527005182
• UDI-Public: (01)20884527005182(17)290115(10)2404400070
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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
• Operator of Device: Health Professional
• Device Model Number: 8888160556
• Device Catalogue Number: 8888160556
• Device Lot Number: 2404400070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2025
• 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: Male