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

Catalog Number 383516

Device Problems Loose or Intermittent Connection (1371); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/30/2018

Event Type  malfunction  

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 bd nexiva¿ closed iv catheter system there was a loose/missing the plug which resulted in blood leakage.The consumer stated that ¿multiple nurses are experiencing the vent plugs falling off even when they were secured (from multiple gauges of the nexivas), they were off when the package was opened, or were pushed off with just the pressure of the blood flowing down the iv tubing when a vein was accessed.A nurse obtained the an iv, felt something warm on her leg and saw the plug was absent, and blood was running onto her scrub pants.She did not find the vent plug¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

All relevant samples and challenges were performed per specification and in accordance with the in-process sampling plan on this batch.Qn database review - no reject activities related to this defect were found for this batch.Eura review - rm5769 rev 14(m) nexiva a-eura identifies detached vent plug as a failure mode.Based on the customer's verbatim description, the effect of the defect was minor leakage that did not require medical intervention.This effect has a limited severity of s2.Occurrence of the this defect for this batch is remote (=10 ipm).With negligible severity and remote occurrence, the risk to the end user is acceptable.No sample was received for testing or evaluation.The customer's experience could not be confirmed.Although the loose vent plug could not be confirmed for this incident, it has been previously investigated.The defect of ¿flow plug-loose-missing¿ is a known issue.The vent plug is inserted into the luer adapter at a specified force in manufacturing.When the nexiva product goes through sterilization the fit between the vent plug and luer adapter becomes loose due to material relaxation.Based on the customer's verbatim description, the root cause of the reported leakage is the loose vent plug.Root cause of the reported incident is related to the product design.Per d16383 rev4(c) nexiva instructions for use single port, it should be verified that the vent plug is secured prior to insertion of the device.Severity is limited and occurrence remote (=10 ipm).A formal corrective action will not be initiated at this time.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.

• Brand Name: 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
• MDR Report Key: 7403676
• MDR Text Key: 104811229
• Report Number: 1710034-2018-00159
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835165
• UDI-Public: 30382903835165
• Combination Product (y/n): N
• PMA/PMN Number: K161777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 10/03/2020
• Device Catalogue Number: 383516
• Device Lot Number: 7325634
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other