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

Model Number 8888160424

Device Problem Unintended Ejection (1234)

Patient Problem No Information (3190)

Event Date 08/11/2018

Event Type  malfunction  

Event Description

Umbilical arterial central line was placed on premature infant shortly after birth.The next day, rn noticed that there was leaking from the line near the hub of the line.Line was removed immediately.

• Brand Name: ARGYLE
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 7822033
• MDR Text Key: 118399420
• Report Number: 7822033
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888160424
• Device Catalogue Number: 8888160424
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/20/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Weight: 2