Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. NEXIVA 20 GA X 1-3/4 IN SINGLE PORT INTRAVASCULAR CATHETER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. NEXIVA 20 GA X 1-3/4 IN SINGLE PORT INTRAVASCULAR CATHETER Back to Search Results
Model Number 383518
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 08/03/2020
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 20 ga x 1-3/4 in single port had incorrect labeling. This was discovered before use. The following information was provided by the initial reporter: material no. 383518, batch no. 9325203. It was reported that package contained the wrong product, incorrect labeling.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNEXIVA 20 GA X 1-3/4 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
8015652341
MDR Report Key10451389
MDR Text Key205283414
Report Number1710034-2020-00533
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 09/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2020
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number383518
Device Catalogue Number383518
Device Lot Number9325203
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/21/2019
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: 08/25/2020 Patient Sequence Number: 1
-
-