Events

Field Safety Notices about ARROW® Kits with BD Eclipse ™ Needles

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 Arrow International.

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
  • Date
    2017-04-10
  • 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
    According to the contents of a letter from bd (copy attached), becton-dickinson (bd) has received reports on the removal of the safety cap and injuries from needle punching with a bd eclipse ™ needle. according to customer reports, in some cases, pushing the safety cover over the needle will cause it to fall off, resulting in needle exposure, which can increase the risk of injury from the needle stick. some customer reports state that a "click" is heard before the safety cap is locked (before it is activated), followed by a second "click" when the safety cap is locked over the needle. this can increase the risk of needle stick injuries if the user assumes that the safety cap is locked after the initial "click".

Device

ARROW® Kits with BD Eclipse ™ Needles

Manufacturer

Arrow International