Events

Alerte De Sécurité sur 5mL Disposable Syringe Descarpack, Luer Lock nozzle, Registration no. 10330669025, lot: SSLLOO87, date of manufacture 03/2012, expiration date. 03/2017.

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 Descarpack Descartáveis do Brasil 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
    1277
  • Date
    2013-07-29
  • 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 company states that the foreign body identified in the syringe was in the packaging of the product, not in its interior, pointing out possible problem in the packaging process (referring to the use of personal protective equipment - PPE).
  • Cause
    According to the cvs - 40 - gt correlatos / ditep communiqué, dated april 22, 2013, the adolfo lutz institute issued the 1743.00 / 2013 analysis report and the single sample tax analysis expert report, with an unsatisfactory conclusion in the appearance (foreign body presence) for the product disposable syringe 5ml disposable descarpack, luer lock nozzle, registration no. 10330669025, lot: sslloo87, date of manufacture 03/2012, expiration date 03/2017.
  • Action
    The company is collecting the product and asks users and patients to inform the SAC of the company, if they identify this lot of the product, by telephone (11) 3649-5555 and e-mail: sac.sc@descarpack.com .br ///////// UPDATE - 06/02/2014 - The company sent documentation informing about the completion of the field action and destruction of the collected units.

Device

5mL Disposable Syringe Descarpack, Luer Lock nozzle, Registration no. 10330669025, lot: SSLLOO87,...

Manufacturer

Descarpack Descartáveis do Brasil Ltda