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

Model Number	8888160333
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
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 3.5fr single lumen catheter was dropped on to the sterile field.It was noted that the end of catheter where the stopcock would be connected had broken off.There was no harm reported.
Additional Manufacturer Narrative
The device history record (dhr) for lot 2332400065 was reviewed and no anomalies related to the reported issue were observed.A device was received for evaluation, and the reported condition was observed.The root cause is attributed to incorrect placement of the catheter on mold, resulting in the catheter breaking at the junction between the extension and the adapter.As an action plan, a quality alert has been created to prevent the recurrence of the reported issue during the manufacturing process.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; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 23888242
• Report Number: 1423537-2025-00517
• Device Sequence Number: 14645244
• Product Code: FOS
• UDI-Device Identifier: 20884527005113
• UDI-Public: (01)20884527005113(17)281020(10)2332400065
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K130725
• 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
• Report Date (Section B): 01/23/2026

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
• Device Lot Number: 2332400065
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 01/23/2026
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown