Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
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B. braun medical inc. (bbmi) has identified the instruction for use (ifu) on the caresite luer access device (product 415128) exhibits translated instructions in the incorrect section and/or partially missing translation instructions. specifically the french section is primarily spanish and the spanish section is primarily italian. it should be noted all other content information including the warning section is translated correctly and accurate on the ifu. at this time no patient harm or adverse impact has been noted as a result of this issue.