• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COVIDIEN, LLC ARGYLE CATHETER, UMBILICAL ARTERY Back to Search Results
Model Number 3.5F LUER LOCK
Device Problems Fluid 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARGYLE
Type of DeviceCATHETER, UMBILICAL ARTERY
Manufacturer (Section D)
COVIDIEN, LLC
15 hampshire street
mansfield MA 02048
MDR Report Key5376122
MDR Text Key36235933
Report Number5376122
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 11/16/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number3.5F LUER LOCK
Device Catalogue Number8888160333
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2015
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/16/2015
Event Location Hospital
Date Report to Manufacturer11/16/2015
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-