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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Since august 2009 smiths medical has received a total of 3 complaints regarding the introducer sheath and the introducer opening being too small for the width of the catheter experienced with port-a-cath and port-a-cath ii implantable venous and arterial access systems and introducer sets. there have been no reports of patient injury or death associated with this issue. investigation of this issue has identified the root cause to be related to the incorrect size introducer being used in several lots of finished goods. an in-depth investigation concluded that the incorrect introducer size was limited to 1 component part (from st. jude medical) which were put into production of 36 smiths medical finished goods lot numbers.