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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 DUAL PORT CATHETER SYSTEM INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA CLOSED IV DUAL PORT CATHETER SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Model Number 383531
Device Problem Leak/Splash (1354)
Patient Problem Chemical Exposure (2570)
Event Date 11/25/2020
Event Type  malfunction  
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 the bd nexiva¿ closed iv dual port catheter system leaked chemotherapy medicine onto the patient's skin from the damaged q-syte. This complaint was created to capture the 1st of 3 related incidents. The following information was provided by the initial reporter: "upon connecting chemotherapy they noticed the patients arm was wet. Chemo was therefore leaking from the q-syte. This happened on 3 separate occasions on the 25 & 26th of november. Leakage observed where the q-syte attaches to the straight line on the extension set piece of the nexiva device, on all 3 occasions. Patients skin exposed to chemo drugs. ".
 
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Brand NameBD NEXIVA CLOSED IV DUAL PORT 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
8015296192
MDR Report Key11069277
MDR Text Key226003969
Report Number1710034-2020-00824
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K183399
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number383531
Device Catalogue Number383531
Device Lot Number0139795
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/18/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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