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

Model Number 8888160531

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 04/05/2021

Event Type  Injury  

Event 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
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 11684776
• MDR Text Key: 246027380
• Report Number: 11684776
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 20884527005175
• UDI-Public: (01)20884527005175(17)250330(10)2011900052
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Model Number: 8888160531
• Device Catalogue Number: 8888160531
• Device Lot Number: 2011900052
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 1