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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. NEXIVA 24 GA X 3/4 IN SINGLE PORT INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. NEXIVA 24 GA X 3/4 IN SINGLE PORT INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383511
Device Problem Difficult or Delayed Activation (2577)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that nexiva 24 ga x 3/4 in single port needle disengagement was difficult. The following information was provided by the initial reporter: during operation check before catheter placement, the hcp felt a strong resistance when withdrawing the needle.
 
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Brand NameNEXIVA 24 GA X 3/4 IN SINGLE PORT
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 Key11335891
MDR Text Key232168742
Report Number1710034-2021-00113
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
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 04/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383511
Device Lot Number0163980
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 Received04/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/11/2020
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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