Events

Alerte De Sécurité sur Trade name: Vacuum suction drain Technical name: Drain ANVISA registration number: 10256400033 Hazard class: II Affected model: 3600-100; 3600-150; 3600-170; 3612-100; 3612-400; 3620-100; 3650-100; 3652-100; 2002-000; 2002-300; 2002-400; 2002-050; 2020-000; 2020-300; 2012-320; 2050-000; 2050-300; 4000-100N; 4000-100P; 4020-100N; 4050-100N; 4050-100P; 16400; 19930, 3300-170; 4000-170N; 4050-170N; 2002-057; 2002-070; 2002-100; 2002-330; 2020-100; 2012-330; 2050-070; 2052-000; 2052-300; 2002-040

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 Atrium Medical Corporation.

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
    2068
  • Date
    2017-01-09
  • 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
    According to the company to introduce the thoracic drain into the sterile field: 1. Remove the thoracic drain wrapped from the protective cap. 2. Open the 2 sterilization wrappers using the sterile technique. 3. Only insert the thoracic drain into the sterile field. This Field Notification is applicable to all Atrium thoracic drainage products listed in Table 1 (see Appendix 1) with an expiration date prior to October 2019. NEW WARNING LABEL: Atrium Thoracic Drains manufactured after October 18, 2016 will contain a new warning label that identifies the pouch as not constituting a sterile barrier and warns the user that only the thoracic drain can be introduced into the sterile field.
  • Cause
    The company provides clarification on the current packaging configuration of atrium ocean, oasis, express and express mini thoracic drainage products. atrium thoracic drainage products are packaged in a dual sequential, sterile casing and placed in an outer protective cap. the protective cover is folded and protected with the label on the packaging. this packaging system is the same configuration used in atrium thoracic drainage products for the last 30 years. this field notification is intended to provide clarification as to which part of the conditioned drain is safe. the label on the outer carton denotes the product as being sterile. the thoracic drain inside the package is sterile; the outer protective cap is not sterile. the two sterilization wraps are what provide the sterile barrier to the product. inform the responsible personnel about the next steps to introduce the atrium thoracic drains into the sterile field.
  • Action
    Field Action Code 001/2016 triggered under the responsibility of the company Biomedical Scientific Medical and Hospital Products. Company will update, correct or supplement the instructions for use.

Device

Trade name: Vacuum suction drain Technical name: Drain ANVISA registration number: 10256400033 Ha...

Manufacturer

Atrium Medical Corporation
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    ANVSANVISA