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

Model Number 8888160648

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 03/31/2021

Event Type  malfunction  

Event Description

A cardiac patient had a triple lumen umbilical vessel catheter and after placement, multiple fluid boluses and drips were ordered.The providers requested the bedside nurse hand push boluses instead of running them on a pump.The nurses had a hard time hand pushing the meds because there was a lot of resistance.It was discovered that there was a crack in the tertiary lumen after the echo tech felt the fluid from the boluses splashing him.Neonatal nurse practitioner was notified and replaced the triple lumen umbilical vessel catheter with another.

• Brand Name: ARGYLE
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 11692843
• MDR Text Key: 246277016
• Report Number: 11692843
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888160648
• Device Catalogue Number: 8888160648
• Device Lot Number: 1921900151
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/05/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 6 DA