• 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 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM 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. 20 G X 1.00 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383516
Device Problem Difficult to Remove (1528)
Patient Problems Exposure to Body Fluids (1745); Hepatitis (1897)
Event Date 10/16/2017
Event Type  Injury  
Manufacturer Narrative
Investigation: device/batch history record review: findings: dhr review was performed on the following. Lot number: 7207649 ¿ the lot number was built on nfa #1, from july 28, 2017 thru august 3, 2017. Per review of the dhr it was concluded that all required challenges samples and testing was performed per specification in accordance with the in-process sampling plans. Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product. Qn / sap database review: the qn reviewed revealed no related reject activity for the sub-assembly lot number associated with this incident. Eura (end user risk analysis) review: the root cause of the defect difficult disconnection from the luer adapter for this incident is indeterminate. Based on the customer's verbatim description and further information provided from the customer, the effect of this failure is mucocutaneous exposure with blood borne pathogen seroconversion with a severe severity of ranking s4. Occurrence of this defect is low for this batch. During the manufacturing process, there are several process steps in which the luer adapter can be internally damaged and potentially affect the ease of disconnection. (b)(4) nexiva p-eura has addressed these steps and evaluated the risk to the end user associated with each. Mucocutaneous exposure with blood borne pathogen seroconversion is identified as a potential effect for each. However, there is no evidence to suggest or support that the defect was caused during the manufacturing process. (b)(4) nexiva a-eura does not assess end user risk for the application step of disconnecting from the luer adapter. Ecr (b)(4) has been created to update the document to assess these risks. Visual analysis observations and testing: received one unused nexiva 20g unit in a sealed package from the lot number 7207649; also received one unused extension set and one unused primary set in sealed packages. Visual/microscopic examination: observed there was no mechanical/physical damage to the nexiva unit. There were no cracks, breaks, grooves, thread damage or mis-molds to the straight adapter. Functional (attach and detach connection lines): using a lab supplied artificial vein with a red dye/water mix performed a simulation of the venipuncture. Attached each of the extension set tubes to the port connection of the straight adapter. All connections and disconnections were successful; met no resistance and attached and detached with ease. The red dye/water mix did not splash or spill out. Test description method no results visual/microscopic n/a see observations and testing functional n/a see observations and testing iso (b)(4) test n/a see observations and testing. Investigation samples(s) meet manufacturing specifications: yes; the returned unit provided for evaluation met and performed to manufacturing specification in relation to the reported incident. Conclusions: the defects blood excess/splash/spill/exposure, blowing veins or other; as the reported codes were not confirmed with the returned unit. The returned unit did not display any adverse characteristics that would contribute to the defects the customer experienced, per the pir. The defects described in the incident report could not be confirmed or replicated with the returned unit. The actual unit described in the incident report was not returned for evaluation. The customer experienced was not confirmed based on the evaluation and testing that was performed on the returned unit. Reproduction of the customer¿s experience was not achieved with the testing performed on the returned unit. Comment: there was no definite physical or mechanical evidence that confirmed and supported manufacturing process related issues for the defect observed in this incident. A corrective action will not be initiated at this time.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported during use of the 20 g x 1. 00 bd nexiva¿ closed iv catheter system the health care professional attempted iv access with catheter tubing filling with blood however had to remove the iv catheter (which was already attached to iv tubing) because the site blew. After getting another iv access, health care professional attempted to remove the 1st iv catheter (w/tubing filled with blood) from the iv tubing. As often occurs, it was difficult to remove the catheter from the iv tubing. When health care professional was able to detach the iv catheter from the iv tubing, blood flew into her eye. The doctor that performed her exam said that this was the second occurrence with the same situation. Patient was found to be (b)(6).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name20 G X 1.00 BD NEXIVA¿ CLOSED IV 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
8015652845
MDR Report Key7010221
MDR Text Key256451496
Report Number1710034-2017-00315
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 health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Catalogue Number383516
Device Lot Number7207649
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/26/2017
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: 11/08/2017 Patient Sequence Number: 1
-
-