MAUDE Adverse Event Report: COVIDIEN, LLC ARGYLE; CATHETER, UMBILICAL ARTERY

Model Number 3.5F LUER LOCK

Device Problems Fluid/Blood Leak (1250); Improper Flow or Infusion (2954)

Patient Problem No Information (3190)

Event Date 10/25/2014

Event Type  malfunction  

Event Description

Upon line change at 2020, rn noted that the uac was leaking directly below the hub.Blood backing up the line.Peds surg team paged.Doctors in to assess.Line repaired successfully per policy.Fluids restarted at 2145, waveform optimal.

• Brand Name: ARGYLE
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN, LLC; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 5376122
• MDR Text Key: 36235933
• Report Number: 5376122
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/16/2015

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?: No
• Device Operator: No Information
• Device Model Number: 3.5F LUER LOCK
• Device Catalogue Number: 8888160333
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/19/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1