Alerte De Sécurité sur Trade name: - BD Phoenix Gram Negative; BD Phoenix Gram Negative Panels. Technical Name: Microorganism Identification / Antibiogram Device. ANVISA registration number: 10033430636; 10033430734. Class of risk: II. Affected Model: BD Phoenix NMIC - 203; BD Phoenix NMIC / ID-94; BD Phoenix. Serial numbers affected: PX2049; PX2078; PX2120; PX2098; PX2063; PX2079; PX2097; PX2099; PX2121; PX2134

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 Indústrias Cirúrgicas Ltda.; Becton Dickinson and Company..

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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.

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  • Type d'événement
    Safety alert
  • ID de l'événement
  • Date
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • 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 institution does not discard, return, or discontinue use of the product. The institution should: 1. Share this notification with any other users of this product (s) in your institution to ensure that everyone is aware. 2. Perform an alternate test method before reporting "sensitive" (S) results for Colistin (CL). A "resistant" result for Colistin from Phoenix does not require an alternate test. 4. Notify the BD of any adverse events that have occurred in relation to the situation described in this notification, whether an event that has affected the outcome of the sensitivity test (post-confirmation with reference method) or patient treatment, in of the erroneous result released as described above. 5. Check the actions provided in the letter that can be used to suppress sensitivity to colistin if necessary according to the institution's procedures. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 01/15/2018 - Date of notification notice to Anvisa: 01/26/2018 The company that owns the affected product is responsible for contacting its customers in due time. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Cause
    Following the tests, bd identified an increase in very major errors (vme) for colistina with strains of enterobacteriaceae (17.5%), e. cloacae (85.3%), e. coli (20.0%) and k , pneumoniae (16.2%), a. baumannii (37.5%) and p. aeruginosa (50.0%) resistant to colistin. these resistant strains may cause a false-sensitive result. after the tests it was concluded that the panels continue to perform as expected and the possible alteration in the sensitivity test occurs as a function of a new emerging resistance to colistin.
  • Action
    Field Action Code 09_Jan18 triggered under the responsibility of the company Becton Dickinson Indústrias Cirúrgicas Ltda. Will notify customer.