Events

Safety Alert Or Field Safety Notices for Alaris Smartsite Add-On Bag Access device

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 BD.

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
  • Date
    2018-06-21
  • Event Date Posted
    2018-06-21
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/alaris-smartsite-add-on-bag-access-device-removal-and-destruction-of-specific-batches-due-to-risk-of-disconnection-or-leakage-mda-2018-021
  • 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
    Manufactured by bd (formerly carefusion) – specific batches manufactured from july 2015 to sept 2016 inclusive. risk of leakage or disconnection of tubing caused by inadequately sealed connections. this may cause delay to infusion, under infusion, or exposure to hazardous infusates.
  • Action
    Refer to the manufacturer’s Field Safety Notice (FSN) for further details of affected products. Identify, quarantine and destroy affected devices as per local procedure.

Device

Alaris Smartsite Add-On Bag Access device
  • Model / Serial
  • Manufacturer
    BD

Manufacturer

BD