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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN ARGYLE CATHETER, UMBILICAL

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COVIDIEN ARGYLE CATHETER, UMBILICAL Back to Search Results
Lot Number 1905000066
Device Problem Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 08/19/2019
Event Type  malfunction  
Event Description
The rn the was drawing blood off of umbilical arterial line. While the blood was flowing back into the syringe, the rn noticed very small drops of blood coming from the base of the catheter where it turns into the hub that connects to the arterial transducer. The catheter did not visibly look broken but when the blood was cleaned off, more would start to form around the outside of the catheter. The amount of blood loss was very minimal. The catheter where leak was occuring was covered with a tegaderm. Doctor was called and removed the catheter. A new catheter was placed.
 
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Brand NameARGYLE
Type of DeviceCATHETER, UMBILICAL
Manufacturer (Section D)
COVIDIEN
15 hampshire st
mansfield MA 02048
MDR Report Key9174900
MDR Text Key161827329
Report Number9174900
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number1905000066
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/23/2019
Event Location Hospital
Date Report to Manufacturer10/10/2019
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

Patient Treatment Data
Date Received: 10/10/2019 Patient Sequence Number: 1
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