Events

Alerte De Sécurité sur BAXTER EQUIPMENT FOR PACLITAXEL WITH AIR INPUT .. Class of Risk II. Anvisa Record: 10068390316.

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 Baxter Hospitalar 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
    862
  • Date
    2007-04-17
  • 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
    Baxter Hospitalar Ltda has informed that it will collect specific batches of the product PACLITAXEL EQUIPMENT WITH AIR INLET, due to complaints from users regarding leakage during use. Equipment that has leaks should be kept in a sealed and quarantined container and gloves should be used to handle the material (due to the toxic potential of Paclitaxel). Anvisa's Technovigilance Unit is following up on this case. ######## Update (23/08/2007): Baxter Ltda has notified the Anvisa Technovigilance unit (UTVIG / NUVIG / ANVISA / MS) that closed the action of collecting the product EQUIPMENT FOR PACLITAXEL WITH AIR INPUT, presenting the documentation regarding the destruction of the product. According to the company, of the 24,285 units sold, 9,592 units were collected and destroyed.
  • Cause
    Leaks occur while using the equipment. product code: amc9627. defective lots: 05i19v810, 06d12v006, 06e01v313, 06g04v003 and 06h04v319.
  • Action
    Baxter Hospitalar Ltda, the company that markets the product in Brazil, communicated the Anvisa's Technovigilance Unit on the quality deviation of the product in question. The company informed that it has already initiated the procedure of recollection with the customers, sending letters of communication to them. UPDATED 10/08/2007: Baxter Hospitalar Ltda has notified the Anvisa Technovigilance Unit that has already terminated the action of collecting and destroying the defective batches of the product Equipment

Device

BAXTER EQUIPMENT FOR PACLITAXEL WITH AIR INPUT .. Class of Risk II. Anvisa Record: 10068390316.

Manufacturer

Baxter Hospitalar Ltda.
  • Source
    ANVSANVISA