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.
데이터 추가 비고
원인
Cracks in silicon extension tubing of hemodialysis catheters propagate over time resulting in holes because of inadequate use during the insertion procedure that is the extension line clamp is clamped onto the guidewire. the hole in the extension tubing leaks when the device is being pressurized with a syringe during flushing or during dialysis treatment.