Events

Alerte De Sécurité sur Product name: PERCUTANEOUS ACCESSORY ASSEMBLY (ANVISA registration number: 10212990312) /// Affected model (s): NPAS-104-HC-NT-U-SST /// Product hazard class: II.

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 E. TAMUSSINO & CIA. LTDA.; COOK INCORPORATED..

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
    1895
  • Date
    2016-05-10
  • 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
  • Cause
    The company reports that "a degradation of the polymers forming the tip of the catheter has been identified resulting in the division or separation of the catheter tip. potential adverse events may occur as a result of degradation of the catheter tip polymer and these effects include: loss of device function, separation of a segment from the device, and may lead to medical intervention to recover separate segment, or complications resulting from this separation in the system as an obstruction of blood flow to the terminal organs. ".
  • Action
    Classification of risk: III /// Classification of the field action: collection with subsequent return to the manufacturer /// Field action code: T10071-32, T10071-34, T10071-35, T10071-36, T10071-37, T10071-38, T11747-3, T11747-6, T11747-8 /// Recommendations to users and patients: A) Analyze whether these recall items are still physically in their inventory, then items should be immediately segregated; b) Contact E. Tamussino & Cia Ltda so that we can align the return of these catheters; c) Circulate the Recall Notice internally for all interested / affected parties; d) Inform E.Tamussino if any of the devices mentioned in this notice have been distributed to other organizations. Please provide contact details so that E.Tamussino can inform recipients accordingly; e) If you are a Distributor, please note that you are responsible for notifying your affected customers.

Device

Product name: PERCUTANEOUS ACCESSORY ASSEMBLY (ANVISA registration number: 10212990312) /// Affec...

Manufacturer

E. TAMUSSINO & CIA. LTDA.; COOK INCORPORATED.
  • Source
    ANVSANVISA