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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD NEXIVA CATHETER INTERVASCULAR CATHETER

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BECTON DICKINSON UNSPECIFIED BD NEXIVA CATHETER INTERVASCULAR CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problem Positioning Failure (1158)
Patient Problems Extravasation (1842); Infiltration into Tissue (1931)
Event Date 10/16/2019
Event Type  Injury  
Manufacturer Narrative
Device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown. Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.
 
Event Description
It was reported that an unspecified number of an unspecified bd nexiva catheter experienced infiltration which was noted during use, and was involved in a serious injury when the device infiltrated into the patient's arm tissue. The following information was provided by the initial reporter: material no. : unknown batch no. : unknown. Complaint 2 of 3. Per email: it is my understanding that you are receiving complaints about extravasation of isovue into patients arms during ct procedures using nexiva and nexiva diffusics. Currently you do not have product or lot numbers. This has happened at least 4 times over the last few weeks. The techs or rns in the er are placing the lines and report easy insertion and brisk blood return. During injection the contrast is not moving up the arm vein, however, it is pooling in the patients arms. The patients are reporting no pain and there is no swelling related to the injection. This sounds like the device was not in the patients vein since no contrast went up the arm and it infiltrated into the arm tissue.
 
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Brand NameUNSPECIFIED BD NEXIVA CATHETER
Type of DeviceINTERVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9306802
MDR Text Key173932355
Report Number2243072-2019-02530
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
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 Received10/21/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 11/11/2019 Patient Sequence Number: 1
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