Events

Safety Alert for Commercial name: BD Phoenix Gram Negative /// Technical name: Identification device / antibiogram of microorganisms /// ANVISA registration number: 10033430636 /// Risk class: II /// Whereas cefepime is present in BD Phoenix panels Gram Negatives, all panels that are already used, ie panels already registered with ANVISA, and potential panels to be used, ie panels that are to be registered, were included in the Client Notification. Registered panels: BD Phoenix NMIC / ID - 123; BD Phoenix NMIC-123; BD Phoenix NMIC-129; BD Phoenix NMIC / ID-124; BD Phoenix NMIC / ID-126; BD Phoenix NMIC / ID-129; BD Phoenix NMIC / ID-132; BD Phoenix NMIC-133; BD Phoenix NMIC / ID-121; BD Phoenix NMIC-140; BD Phoenix NMIC / ID-94; BD Phoenix NMIC - 203 // Panels to be registered: BD Phoenix NMIC / ID-406; BD Phoenix NMIC-406; BD Phoenix UNMIC / ID-407; BD Phoenix UNMIC-407.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Becton Dickinson and Company; Becton Dickinson Indústrias Cirúrgicas 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
    1984
  • Date
    2016-09-14
  • 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
    The BD recommends that the lab verify the current BD Phoenix System settings to ensure that the default configuration has not been modified. If the rules specified in the letter sent to users are disabled, BD recommends that the default setting be restored.
  • Reason
    The company states that "a new strain isolate of klebisiella pneumonia has been identified. the new isolate presents a change in the susceptibility test to cefepime present in phoenix gram negative panels. the new isolate may give a false susceptible result. after investigation with several strains of this microorganism it was concluded that the phoenix system and the panels continue to perform as expected and that the possible change in the susceptibility test occurs as a function of the change of the microorganism.
  • Action
    The company informs that the data of the BD Phoenix Gram negative panels are performing as expected, as there was a change in the strain of the microorganism. Therefore these Products are not under risk. Also regarding the possibility of release of false susceptible result, the Phoenix BD System has features that automatically correct the result or send alert message to the health professional of the Laboratory. Assuming that a false susceptible result is released, the risk is associated with inappropriate antibiotic use.

Device

Commercial name: BD Phoenix Gram Negative /// Technical name: Identification device / antibiogram...

Manufacturer

Becton Dickinson and Company; Becton Dickinson Indústrias Cirúrgicas Ltda