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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA SINGLE PORT 20GA 1.00IN (1.1 MM X 25 MM) INTERVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA SINGLE PORT 20GA 1.00IN (1.1 MM X 25 MM) INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383516
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/03/2019
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It has been reported that one bd nexiva single port 20ga 1. 00in (1. 1 mm x 25 mm) has been found with tubing expanding during use. The following has been provided by the initial reporter: material no: 383516, batch no: unknown. It was reported that during a ct scar the iv tubing became swollen/engorged as if it was going to burst. No kinks were noted in the catheter after it was removed to be assessed. Event description per attached email states, it was reported that during the ct scan of a patient ( chest abdomen and pelvis) the iv tubing became swollen/engorged as if it was going to burst. The test was stopped and the iv was assessed, there were no kinks noted in the catheter. The iv was discontinued and a new catheter was placed.
 
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Brand NameBD NEXIVA SINGLE PORT 20GA 1.00IN (1.1 MM X 25 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 Key9242138
MDR Text Key174357560
Report Number1710034-2019-01146
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183399
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 11/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383516
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/09/2019
Was Device Evaluated by Manufacturer? Yes
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: 10/25/2019 Patient Sequence Number: 1
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