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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD NEXIVA CLOSED IV CATHETER SYSTEM

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BD BD NEXIVA CLOSED IV CATHETER SYSTEM Back to Search Results
Catalog Number 383512
Device Problems Break (1069); Detachment Of Device Component (1104); Leak/Splash (1354)
Patient Problem No Code Available (3191)
Event Date 05/20/2016
Event Type  malfunction  
Event Description
Part of "bloodless" iv insertion system broke and came out of catheter when needle was withdrawn. According to manufacturer, "our quality engineer microscopically inspected the returned unit and observed bodily fluids around the white septum canister, indicating the septum had leaked. The unit was then dissected and the septum microscopically inspected. The septum was found to be cored, which allowed the reported leakage to occur. This incident is manufacturing/design related and a project has been initiated to address occurrences of this nature. Please note that the engineer did not observe any damage that would contribute to disengagement issues. We appreciate you taking the time to bring this observation to our attention and we regret any inconveniences this incident may have caused you and your facility. This incident has been added to our database of reported incidents. Our business team regularly reviews the collected data for identification of emerging trends. Your assistance in this matter will be helpful in trend identification, driving appropriate corrective actions and supporting our commitment to continuous quality improvement. " dates of use: (b)(6) 2016. Diagnosis: iv medications needed.
 
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Brand NameBD NEXIVA CLOSED IV CATHETER SYSTEM
Type of DeviceNEXIVA CLOSED IV CATHETER SYSTEM
Manufacturer (Section D)
BD
sandy UT 84070
MDR Report Key5764658
MDR Text Key48740915
Report NumberMW5063195
Device Sequence Number1
Product Code FOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 06/28/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number383512
Device Lot Number6091656
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
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

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