Events

Safety Alert for PRESSURE REGULATOR FOR OMRIX APPLICATION DEVICE - Registration 80145909027 - QPR6: MRXQ0053; MRXQ0054; MRXQ0057; MRXQ0063; MRXQ0065; MRXQ0066; MRXQ0067; MRXQ0070; MRXQ0599; MRXQ1059; MRXQ1060; MRXQ1061 ;. MRXQ1062; MRXQ1063; MRXQ1069; MRXQ1072; MRXQ1073; MRXQ1077; MRXQ1170.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by JOHNSON & JOHNSON DO BRASIL INDÚSTRIA E COMÉRCIO DE PRODUTOS PARA SAÚDE LTDA.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1180
  • Date
    2012-09-14
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    Reports of air or gas embolism were reported that occurred in association with the use of spray devices with a pressure regulator to administer EVICEL®. These events appear to be related to the use of the spray device at pressures higher than recommended and / or application closer to the tissue surface than recommended. The risk of air or gas embolism is an identified hazard for all fibrin sealants using air or pressurized gas for product application. To date, there have been no reports of adverse events of air or gas embolism when the spray application technique was used in accordance with the pressure and distance recommendations reported in the product's Instructions for Use (IFU). There are no notification records in the NOTIVISA system. Anvisa follows this Field Action.
  • Reason
    Risk of airborne embolism resulting in shock, hypertension, neurological deficit, cardiac arrest, and death if instructions for use are not followed or if pressure is applied at a greater or greater distance than recommended.
  • Action
    The company recommends the use of CO2 (where possible) as the gas for spray application, as it is more soluble in the blood and has the potential to reduce the damage associated with gas embolism. It is not contraindicating the use of air, since the product can be used with air when the indications of distance and pressure are observed correctly. End-expiratory blood pressure, pulse, oxygen saturation and CO2 should be monitored closely when applying EVICEL® because of the possibility of air or gas embolism. When using accessory tips for laparoscopic surgical procedures in conjunction with EVICEL®, tip tips should be followed for distance and pressure. For customers who confirm the use of one or more Omrix Pressure Regulators at their facility: Fill out the attached business response card and return it to us so we can send a package containing a label and instructions on how to place the label on the Regulator ( ) of Pressure. This label will be a reminder at the point of use on the correct pressure range for EVICEL®.

Device

PRESSURE REGULATOR FOR OMRIX APPLICATION DEVICE - Registration 80145909027 - QPR6: MRXQ0053; MRXQ...

Manufacturer

JOHNSON & JOHNSON DO BRASIL INDÚSTRIA E COMÉRCIO DE PRODUTOS PARA SAÚDE LTDA