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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 12/17/2020
Event Type  Injury  
Event Description
It was reported that 4 bd nexiva¿ closed iv dual port catheter systems leaked chemotherapy medication onto the patient's skin during use. This complaint was created to capture the 3rd of 4 related incidents. The following information was provided by the initial reporter: "an area around the q-syte was leaking. It caused chemotherapy to leak onto the patients skin which is serious. This is the second such incident that has been reported by the hospital. It has happened 4 times. The first two times it happened the staff in the ward the staff thought it might have been a practice error around tightening the q -syte. ".
 
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).
 
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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 Key11181331
MDR Text Key228473328
Report Number1710034-2021-00033
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 04/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2021
Is this an Adverse Event Report? Yes
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 Manufacturer02/12/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2021
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

Patient Treatment Data
Date Received: 01/15/2021 Patient Sequence Number: 1
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