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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD NEXIVA IV NEEDLE

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BD BD NEXIVA IV NEEDLE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Embolus (1830)
Event Date 06/07/2017
Event Type  Injury  
Event Description
Ct exams with issue, approx 3 hours after exams, radiologist when reading exam noted air embolus.
 
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Brand NameBD NEXIVA
Type of DeviceIV NEEDLE
Manufacturer (Section D)
BD
MDR Report Key6633139
MDR Text Key77429377
Report NumberMW5070293
Device Sequence Number1
Product Code FOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
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? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 06/08/2017 Patient Sequence Number: 1
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