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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN ARGYLE CATHETER, UMBILICAL ARTERY

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COVIDIEN ARGYLE CATHETER, UMBILICAL ARTERY Back to Search Results
Model Number 8888160333
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/27/2017
Event Type  malfunction  
Event Description
It was reported to covidien on (b)(6) 2017 that a customer had an issue with an umbilical vessel catheter. The customer states the catheter had a very small crack and leaked fluid out of the line. The catheter had to be pulled and another iv line accessed.
 
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Brand NameARGYLE
Type of DeviceCATHETER, UMBILICAL ARTERY
Manufacturer (Section D)
COVIDIEN
edificio b20, calle #2
alajuela 0101
Manufacturer (Section G)
COVIDIEN
edificio b20, calle #2
alajuela 0101
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
5084524151
MDR Report Key6343210
MDR Text Key67830799
Report Number3009211636-2017-05009
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 Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 01/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160333
Device Catalogue Number8888160333
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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