Events

Field Safety Notices about BD Eclipse™ Injection Needle and others

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia 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
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Bd has received reports of safety cover/shield disengagement, which has the potential to lead to a needlestick injury (nsi) when using the bd eclipse™ injection needle and bd preset™ eclipse™ arterial blood collection syringes. based on the customer reports, in some cases when the safety cover/shield is pushed over the needle it disengages, resulting in an exposed needle which can increase the risk of nsi. some customer reports indicate an audible “click” sound before the safety cover/shield is locked (activated) followed by a second “click” sound when the safety cover/shield is locked over the needle. this may potentially increase the risk of nsi if the user assumes the safety cover/shield is locked after the initial “click”. .

Device

BD Eclipse™ Injection Needle and others
  • Model / Serial
  • Manufacturer
    BD

Manufacturer

BD