Safety Alert for ELS SYRINGE FOR ANGIOGRAPHY GUERBET - Model: 00 000 000 3160 25, Registro ANVISA: 10061400027

Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.

Blue particles from the protective caps of the syringes may eventually come loose into the syringes. This occurs due to friction in the material when the protective cap is threaded during the syringe manufacturing process. The friction can cause wear and consequently, the particle generated in this friction can fall into the syringe. The cause identified for this quality deviation was a tool modification by the manufacturer of the product. The consequences may range from local redness to involvement of the microcirculation with blood vessel obstruction and phlebitis, as well as possible damage to organs such as the lungs, liver, kidneys and spleen due to the formation of granulomas. According to the registry holder in Brazil, no incident notification has been received so far. The actions have already been taken by the manufacturer and the problem has been eliminated in production. In order to avoid any risk to patients, the involved lots will be collected and destroyed.