Events

Field Safety Notices about Bard TruGuide® Disposable Coaxial Biopsy 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 Bard 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
  • 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
    Bard confirmed that for products with the product code / serial number combinations listed in table 1 above, there is a risk of having a non-sized, tip-size probe that cannot be inserted into the coaxial line. the product should normally contain a 19ch thick probe, but there is a possibility that the packaged product may actually contain a 17 ch thick probe. .

Device

Bard TruGuide® Disposable Coaxial Biopsy Needles
  • Model / Serial
    C2016B REXB1529 C2016B REXC1632
  • Manufacturer
    Bard Limited

Manufacturer

Bard Limited