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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD NEXIVA CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER
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BD BD NEXIVA CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383641
Device Problem Insufficient Information (3190)
Patient Problems Edema (1820); Hyperthermia (1909); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Staphylococcus Aureus (2058); Skin Discoloration (2074)
Event Type  Injury  
Event Description
Inflammation occurred at the infusion site when using a bd nexiva device.The infection syndrome was manifested by hyperthermia at 38.9 degrees c and inflammation of the right leg with redness, heat, pain and edema.Blood cultures performed during the infectious episode showed staphylococcus epidermidis.
 
Manufacturer Narrative
The sample is not available for evaluation.Upon completion of the investigation, a supplemental report will be submitted.
 
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Brand Name
BD NEXIVA CLOSED IV CATHETER SYSTEM
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BD
one becton drive
franklin lakes NJ 07417
Manufacturer Contact
amy bodell
one becton drive
franklin lakes, NJ 07417
8015652585
MDR Report Key3926128
MDR Text Key4669036
Report Number2243072-2014-00138
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 07/01/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/31/2016
Device Catalogue Number383641
Device Lot Number3081877
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/19/2014
Initial Date FDA Received07/01/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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