MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 20 G X 1.00 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

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

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).

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.

• Brand Name: 20 G X 1.00 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR 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 Key: 7010221
• MDR Text Key: 91358662
• Report Number: 1710034-2017-00315
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835165
• UDI-Public: 30382903835165
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161777
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 383516
• Device Lot Number: 7207649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2017
• Initial Date FDA Received: 11/08/2017
• Supplement Dates Manufacturer Received: 10/16/2017
• Supplement Dates FDA Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention