Events

Field Safety Notices about Single-Needle Adapter

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 B. Braun Avitum AG.

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
    2018-07-26
  • 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
    During continuous post-market surveillance we became aware of a disconnection of the female luer-lock connector from the venous side of the single-needle adapter leading to blood loss for the patient. the dialysis machine had triggered an alarm indicating the disconnection and the incident had no consequences for the patient. the investigation showed that the luer-lock connector was not glued to the tube of the single-needle adapter.

Device

Single-Needle Adapter

Manufacturer

B. Braun Avitum AG