Events

Alerte De Sécurité sur Chemical Indicator 3M Comply OE 1251. Lots under risk: 2008-02AA, 2008-03AA, 2008-04AA, 2008-05AA, 2008-08AA, 2008-10AA, 2008-10AB, 2008-12AA, 2009-02AA, 2009-02AB , 2009-04AA, 2009-05AA, 2009-08AA and 2009-09AA. Product exempted from registration with the Ministry of Health.

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 3M 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
    912
  • Date
    2008-05-02
  • 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
    In a routine test conducted by 3M Health Care, a small discrepancy in the production specification was identified in the visual color change of the test strip: while the product label determines that the green color means adequate exposure to ethylene oxide, the product specification allows several color tones - which can also be interpreted as green - to indicate inadequate exposure to Ethylene Oxide. Thus, in cases of inadequate sterilization cycles (with ethylene oxide), false positive results may occur - the tape may be green when it should be red, according to the product label. Such a situation may lead users to incorrectly conclude that the sterilization cycle was adequate. The company 3M do Brasil Ltda reported that it has already sent a letter of communication to the customers involved, with an attached response form, and has already started the procedure for collecting the batches under risk of the product in Brazil. The company also announced that it intends to finalize the collection and replacement of the products until 05/30/2008. Anvisa's Technovigilance Unit is monitoring this case.
  • Cause
    Possibility of ethylene oxide sterilization indicator strip to show incorrect result (false positive).
  • Action
    3M do Brasil Ltda recommends to professionals / users / patients: (a) Discontinuation of the use of batches at risk of the product in question (check the "Product Description" field); (b) The return of the lots at risk to 3M do Brasil Ltda; (c) Resterilization of any products that have been sterilized with the 3M Comply OE 1251 Chemical Indicator (batch number described above) using a 3M Comply OE 1251 Chemical Indicator whose lot number is not under risk, or a product alternative; (d) The risk assessment associated with items that could have been monitored with ethylene oxide sterilization.

Device

Chemical Indicator 3M Comply OE 1251. Lots under risk: 2008-02AA, 2008-03AA, 2008-04AA, 2008-05AA...

Manufacturer

3M do Brasil Ltda.
  • Société-mère du fabricant (2017)
    3m Company
  • Source
    ANVSANVISA