Safety Alert for BD Epilor LOR syringe 7 ml with Luer-Lok nozzle, registration no. 10033430533 - Lots - attachment

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.

If the user does not detect the loss of resistance of the syringe due to the slip with greater resistance that the plunger may present, spinal anesthesia may occur instead of epidural anesthesia. If spinal anesthesia occurs, specific effects with a remote probability of occurrence include headaches and backaches, hypotension, urinary retention, and rare meningitis. Rare effects and unlikely occurrence include severe respiratory depression, hypotension, and decreased heart rate, which requires temporary advanced medical intervention with increased oxygen and administration of medications, or mechanical ventilation until the effects of anesthesia decrease. There are reports of cases in the literature without reports of studies with real incidence, presuming that these types of complications are very rare. In addition, the detection of specific and rarer effects should be part of the routine monitoring of patients receiving anesthesia.////// UPDATE 11/08/2014 - The company finalized the field action. An alert message was sent regarding the use of the product for customers and distributors.