• 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. 20 G X 1.00 IN. (1.1 MM X 25 MM) BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR 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. 20 G X 1.00 IN. (1.1 MM X 25 MM) BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383516
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/15/2017
Event Type  malfunction  
Manufacturer Narrative
Results: the customer's experience could not be confirmed or reproduced as no sample was received for evaluation and testing. The qn database reviewed, and no defects related to separation of adapter from extension tubing were identified during the manufacturing process. Rm5796 rev13(l) nexiva p-eura was reviewed, and the failure mode of extension tubing detaching from the adapter was identified. Based on the verbatim, the effect of the failure was a second piv. The occurence of this defect is low for this batch. No samples were received for evaluation and testing. Root cause is indeterminate.
 
Event Description
It was reported by a nurse that the closed system tubing became detached from the iv catheter on a 20 g x 1. 00 in. (1. 1 mm x 25 mm) bd nexiva¿ closed iv catheter system during/post use. There was no report of injury or medical intervention.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name20 G X 1.00 IN. (1.1 MM X 25 MM) BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
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
8015652845
MDR Report Key7017660
MDR Text Key92370561
Report Number1710034-2017-00309
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161777
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation
Type of Report Initial
Report Date 10/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Catalogue Number383516
Device Lot Number7164957
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/13/2017
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: 11/10/2017 Patient Sequence Number: 1
-
-