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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383647
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem Venipuncture (2129)
Event Date 06/19/2020
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. (b)(4).
 
Event Description
It was reported that redness occurred at the puncture site through the entire length of the bd nexiva¿ closed iv catheter system, causing extravasations that were mainly noticed on the third day of placement. An "x-ray, ct scan, magnet, gastroscopy, and ercp" were performed, antibiotics given, and the catheter was replaced. This complaint was created to capture the 2nd of 2 related incidents. The following information was provided by the initial reporter: "redness occurs at the puncture site through the entire length of the catheter. Moreover, area outside of the fixative is also red what is supported by the image. Furthermore, they also noticed and monitored extravasations due to the insertion of catheter. These situations mostly arises on third day of the catheter insertion which force nurses to replace the catheter. " "x-ray, ct scan, magnet, gastroscopy, ercp, administration of antibiotics. ".
 
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Brand NameBD NEXIVA CLOSED IV CATHETER SYSTEM
Type of DeviceINTRAVASCULAR 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 Key10258917
MDR Text Key198786160
Report Number1710034-2020-00439
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeHR
PMA/PMN Number
K183399
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383647
Device Lot Number9284508
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 Received06/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/11/2019
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: 07/10/2020 Patient Sequence Number: 1
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