Events

Field Safety Notices about BD BBL CHROMagar MRSA II

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 France S.A.S..

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
    2015-07-15
  • 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 has determined through complaint investigation that the above referenced lots of product may exhibit breakthrough growth of methicillin-susceptible s. aureus (mssa) strains. growth of mssa strains on bbltm chromagartm mrsa ii could be observed as mauve colonies and subsequently lead to false positive declaration of mssa strains. this would result in detection of mrsa for mrsa-negative patients.

Device

BD BBL CHROMagar MRSA II
  • Model / Serial
    BD BBLTM CHROMagarTM MRSA II 257434/257435 20/120 ea 5142463 August 4, 2015 BD BBLTM CHROMagarTM MRSA II 257434/257435 20/120 ea 5147498 August 7, 2015 BD BBLTM CHROMagarTM MRSA II 257434/257435 20/120 ea 5148248 August 10, 2015 BD BBLTM CHROMagarTM MRSA II 257434/257435 20/120 ea 5153362 August 18, 2015 BD BBLTM CHROMagarTM MRSA II 257434/257435 20/120 ea 5160473 August 25, 2015 BD BBL™ CHROMagar™ Staph aureus / BBL™ CHROMagar™ MRSA II (Biplate) 257585 120 ea 5147466 August 12, 2015
  • Manufacturer
    Becton Dickinson France S.A.S.

Manufacturer

Becton Dickinson France S.A.S.