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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX ARROW MULTI LUMEN CENTRAL VENOUS CATHETER

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TELEFLEX ARROW MULTI LUMEN CENTRAL VENOUS CATHETER Back to Search Results
Catalog Number CDC-45703-XP1A
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Code Available (3191)
Event Date 11/13/2017
Event Type  Injury  
Event Description
During placement of internal jugular vein catheter, guidewire broke during removal leaving a portion in the patient's left internal jugular and innominate vein requiring removal by interventional radiology.
 
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Brand NameARROW
Type of DeviceMULTI LUMEN CENTRAL VENOUS CATHETER
Manufacturer (Section D)
TELEFLEX
morrisville NC
MDR Report Key7147722
MDR Text Key95954358
Report NumberMW5074252
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCDC-45703-XP1A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 12/26/2017 Patient Sequence Number: 1
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