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

Model Number	8888160531
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
While suturing a umbilical catheter argyle" vessel 3.5 fr.15 inch dual lumen, it inadvertently broke at 8 cm and was unable to be retrieved.A chest x-ray was immediately taken and the line fragment was in the inferior vena cava.The newborn patient was transferred via lifeflight to a children's specialty hospital.The newborn patient was taken to interventional radiology where they were able to retrieve the fragment from the left pulmonary artery.

• Brand Name: ARGYLE
• Common Device Name: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 11684776
• Report Number: 11684776
• Device Sequence Number: 3015519
• Product Code: FOS
• UDI-Device Identifier: 20884527005175
• UDI-Public: (01)20884527005175(17)250330(10)2011900052
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/06/2021
• Report Date (Section F): 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 8888160531
• Device Catalogue Number: 8888160531
• Device Lot Number: 2011900052
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Weight: 1
• Date Report Sent to FDA: 04/06/2021