Field Safety Notices about SBK incision biopsy needle

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 Angiomed GmbH & Co. Medizintechnik KG.

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
  • Event Source
  • 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
    Through complaints, angiomed has identified products with the combinations of markings and batch numbers listed in annex 1 that may contain a mandrene cap at risk of breakage. if the mandrene cap broke, the user had to remove the needle and re-insert the new needle to complete the biopsy, or abandon the biopsy completely due to certain unforeseen circumstances. our records show that your establishment has purchased one or more units of affected products with combinations of labels and batch numbers. all other products with combinations of markings and batch numbers not listed in the safety corrective action notice may continue to be used at your establishment because they are safe to use and are not subject to this product recall.