Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by Becton, Dickinson And Company.

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
    Recall / Field Safety Notice
  • Event ID
    mdprc 133 05 18 000
  • Event Initiated Date
    2018-05-30
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12689
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Extra notes in the data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    Bd states that it has received reports of users experiencing difficulty or failing to prime the above administration sets. the pump administration sets require priming before patient use as described in the directions for use. bd also states that it is during the priming process that this problem can be observed. during priming, when attempting to fill the drip chamber, the drops into the drip chamber will not be observed once the roller clamp is opened. bd further states that this problem is highly detectable.

Device

BD SmartSite Administration Sets
  • Model / Serial
    10015489, 11426965, 2120-0500, 2420-0007, 2420-0500
  • Product Description
    Infusion Pump Administration Sets
  • Manufacturer
    Becton, Dickinson And Company

Manufacturer

Becton, Dickinson And Company