Events

Field Safety Notices about Certofix Quattro

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 Melsungen 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
    2015-12-14
  • 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
    In the course of internal quality checks we discovered that in certofix quattro minor inter-lumen connections may occur with a very low frequency. the potential inter-lumen connections are fully embedded into the plastic material of the bifurcation hub and a leakage to outside can be excluded.

Device

Certofix Quattro
  • Model / Serial
    4167775S CERTOFIX SAFETY QUATTRO S 820 all 4167767 CERTOFIX QUATTRO V 815 all 4167775 CERTOFIX QUATTRO V 820 all 4167783 CERTOFIX QUATTRO V 830 all 4163443 PROSET CERTOFIX-QUATTRO S830 (APOPLF.) all 4168894 PROSET CERTOFIX QUATTRO S830 all 4163492 PROSET CERTOFIX QUATTRO S820 all 4168208 PROSET CERTOFIX QUATTRO S830 all 4167784S PROSET CERTOFIX SAFETY QUATTRO S820 all 4168178 PROSET CERTOFIX QUATTRO S820 all 4167772S PROSET CERTOFIX SAFETY QUATTRO S820 all 4163443 PROSET CERTOFIX-QUATTRO S830 all 4164038 PROSET CERTOFIX-QUATTRO S820 all 4169960 CERTOFIX QUATTRO S820 W/O ECD DEDUCT all 4169972 CERTOFIX QUATTRO S830 W/O ECD DEDUCTION all
  • Manufacturer
    B. Braun Melsungen AG

Manufacturer

B. Braun Melsungen AG