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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 3.5 FR. SINGLE LUMEN

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COVIDIEN ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 3.5 FR. SINGLE LUMEN Back to Search Results
Catalog Number 8888160424
Device Problems Backflow (1064); Fluid Leak (1250); Connection Problem (2900)
Patient Problem Blood Loss (2597)
Event Date 11/28/2016
Event Type  malfunction  
Event Description
Patient had an uac (umbilical artery catheter) placed at outside facility prior to transfer to hospital with an infusion running. Rn noticed some slight back flow in the catheter and then noticed the catheter was wet. After drying the catheter to watch infusion and determine where fluid leak was occurring, it was determined that at the connection between the line and the connection hub was the location of the leak. Uac was then removed from patient due to leak and risk for infection.
 
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Brand NameARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 3.5 FR. SINGLE LUMEN
Type of DeviceUMBILICAL VESSEL CATHETER
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield MA 02048
MDR Report Key6212182
MDR Text Key63495113
Report Number6212182
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 12/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number8888160424
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/02/2016
Event Location Hospital
Date Report to Manufacturer12/02/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/29/2016 Patient Sequence Number: 1
Treatment
NO
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