MAUDE Adverse Event Report: Cardinal Health 200, LLC Argyle; Catheter, Umbilical Artery

Model Number	8888160333
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the umbilical catheter end did not secure properly to the stopcock.One retained sample reportedly appeared to be missing part of the lip at the catheter end.The clinical staff reported difficulty achieving a secure connection with the stopcock.Additional information was received from the customer and stated that the issue seemed to occur while the line was on.It appeared the lip at the end of the catheter may have been stripped away.There was no harm reported.Unfortunately, the customer did not have any more additional information.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.

• 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 ; +1(508)618-3640
• MDR Report Key: 50731551
• Report Number: 1423537-2026-00281
• Device Sequence Number: 10542722
• Product Code: FOS
• UDI-Device Identifier: 10192253040302
• UDI-Public: (01)10192253040302
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K130725
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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: 08/28/2026
• Initial Report FDA Received Date: 09/11/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown