Events

Safety Alert Or Field Safety Notices for Alaris® SmartSite® needle-free valve

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by CareFusion.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2014/017
  • Event Number
    CON418455
  • Date
    2014-05-21
  • Event Date Posted
    2014-05-21
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON418455?tabName=allTabs
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
  • Extra notes in the data
  • Reason
    Risk of disconnection or inability to disconnect from the smartsite could result in delay to treatment due to: air entering the fluid path replacement of a central catheter or picc under-delivery and leakage of medication. carefusion issued a field safety notice (fsn) in february 2014 providing advice on this problem.
  • Action
    Quarantine affected lot numbers of SmartSite as listed in the Field Safety Notice. Follow instructions in the FSN including returning verification form to CareFusion. Ensure all users are aware of manufacturer’s Field Safety Notice Arrange for replacement devices.

Device

Alaris® SmartSite® needle-free valve
  • Model / Serial
  • Product Description
    Alaris® SmartSite® needle-free valve Product reference: 2000E7D Specific lot numbers The Smartsite is a needle-free IV access device. Affected devices are made from a polycarbonate material. The affected lot numbers are: 13086202, 13086263, 13086309, 13095185, 13095913, 13095914, 13096487, 13096488, 13096489, 13105366, 13105478, 13106563, 13106710, 13106711, 13115316. If relevant to you, the national supply codes are as follows: England NPC: FSW165 Scotland SKU: 066032 Northern Ireland BSO: does not have a PALS reference number Wales NSV: FSN342 Only product code 2000E7D is affected and other configurations or item numbers are not affected. This Medical Device Alert does not affect CareFusion’s MaxPlus or MaxZero needle-free connectors.
  • Manufacturer
    CareFusion

Manufacturer

CareFusion