Events

Field Safety Notices about BD Plastipak™ Syringe, Catheter tip with Luer slip adaptor

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 is conducting a voluntary field safety corrective action for all lots of bd 100ml plastipak catheter tip (ct) syringe labeled with a 5yr expiration date. the syringes are being recalled due to leakage past stopper failures during internal routine real time stability tests, with failures beginning at the 2yr time point. no adverse event has been reported for this issue at this time. although the product can safely be used for 18 months after manufacturing, to avoid mistakes, we are recalling all lots labelled with a shelf life of 5 years. all affected lots are listed in table a below. users should stop using these lots immediately. .

Device

BD Plastipak™ Syringe, Catheter tip with Luer slip adaptor
  • Model / Serial
  • Manufacturer
    BD

Manufacturer

BD