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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MANUFACTURING SOLUTIONS SA CATHETER, UMBILICAL ARTERY

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COVIDIEN MANUFACTURING SOLUTIONS SA CATHETER, UMBILICAL ARTERY Back to Search Results
Lot Number 1521687
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/30/2018
Event Type  malfunction  
Event Description
Leaking umbilical catheter 5 french single lumen.
 
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Type of DeviceCATHETER, UMBILICAL ARTERY
Manufacturer (Section D)
COVIDIEN MANUFACTURING SOLUTIONS SA
15 hampshire street
mansfield MA 02048
MDR Report Key8334697
MDR Text Key136016931
Report Number8334697
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 02/07/2019,10/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number1521687
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/07/2019
Event Location No Information
Date Report to Manufacturer02/13/2019
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?
Type of Device Usage

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