Events

Alerte De Sécurité sur 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.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Becton Dickinson and Company; Becton Dickinson Indústrias Cirúrgicas Ltda.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1984
  • Date
    2016-09-14
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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