Events

Field Safety Notices about BD Plastipak / Oral Syringes

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 Becton Dickinson UK Limited.

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
    2016-11-16
  • 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 communicated in september 2015, via an urgent field safety notice (mss-15-637 fa) that customers had reported reduced potency of certain medications when stored in bd plastic disposable syringes, made with a stopper provided by an alternate supplier. the purpose of this follow-up is to inform our customers about the corrective actions implemented by bd: 1- all syringes currently distributed in ireland by bd are manufactured with a stopper provided by our primary supplier (not affected by the issue), except for the 4 products listed in table a. 2- the syringes in table a are currently manufactured with the stopper from the alternate supplier and are still in distribution in ireland. 3- bd is committed to converting all syringes sold in the eu back to the primary stopper supplier and expects that from july 2017, all syringes supplied to the marketplace will contain the primary stopper only. .

Device

BD Plastipak / Oral Syringes

Manufacturer

Becton Dickinson UK Limited