Events

Alerte De Sécurité sur Autoloid Filter Barrier Bacteria Virus Mechanical Ventilation PALL (Family BB) - REGISTRATION 10234400072 - Validity 04/04/2015. REFERENCE: BB100MFSLA. LOTS: 116406 - 118804 - 131904. THE COMPANY INFORMED THAT IT COULD EXPAND THE FIELD ACTION.

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 Pall Biomedical Products Company.

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
    1157
  • Date
    2012-07-27
  • 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
    Field action motivated by notifications made by NOTIVISA to the National Health Surveillance System - SNVS and customer complaints made to the company. #### Update 13/08/2012: The company increased the collection for product lots produced from 2007 to present. For additional information, consult the update of the alert message published by the company at http://portal.anvisa.gov.br/wps/wcm/connect/3c1079804c5eb4d6be1ffedc39d59d3e/Mensagem_de_Alerta_Atualizacao.pdf?MOD=AJPERES. . #### Update 18/12/2012: The company completed the field action in December 2012, with a total of 5,989 units destined for destruction.
  • Cause
    Incorrect positioning of the orange cap inside the product's corrugated tube. incorrect positioning / placement occurred during the assembly / fabrication process of the product. said lid may come loose inside the carton or attached to the outside of the corrugated tube. failure to observe the problem prior to its use may lead to obstruction of the oxygen passage.
  • Action
    - The company has blocked the lots in its inventory and is in the process of collecting the affected lots; - The company is arranging with ANVISA a change in the Instructions for Use of the product, in order to alert users to the importance of observing, before installation, if the corrugated pipe is unobstructed; - Until the changes in the Instructions for Use are approved by ANVISA, the company is attaching an addendum to the products informing of the need to adopt such precaution; - The company is issuing a Notice to all its customers (regardless of having received the batches affected by the warning recall) regarding the correct use of the product and the use of the orange cap; - Customers of the affected lots are being contacted in order to block the use of the product and the company picks it up; - The collection is being done by sales representatives and technical consultants of the company, who are also communicating the collection action with the customers.

Device

Autoloid Filter Barrier Bacteria Virus Mechanical Ventilation PALL (Family BB) - REGISTRATION 102...

Manufacturer

Pall Biomedical Products Company
  • Source
    ANVSANVISA