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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA DUAL PORT 20GA 1.25IN (1.1 MM X 32 MM) INTERVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA DUAL PORT 20GA 1.25IN (1.1 MM X 32 MM) INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383537
Device Problem Leak/Splash (1354)
Patient Problem Extravasation (1842)
Event Date 12/06/2017
Event Type  Injury  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that an unspecified number of bd nexiva dual port 20ga 1. 25in (1. 1 mm x 32 mm) experienced leakage at the septum and extravasation during use. The following information was provided by the initial reporter: noticed extravasation at the time of the contrast injection, we placed another key and were able to proceed with the examination.
 
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Brand NameBD NEXIVA DUAL PORT 20GA 1.25IN (1.1 MM X 32 MM)
Type of DeviceINTERVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9162516
MDR Text Key161796792
Report Number1710034-2019-01085
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K183399
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other,user facili
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 11/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/30/2018
Device Catalogue Number383537
Device Lot Number5183657
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/02/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/07/2019 Patient Sequence Number: 1
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