Events

Alerte De Sécurité sur MOBICATH Bi-Directional Guiding Sheath

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Greatbatch Ltd..

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
  • Date
    2012-11-19
  • Date de publication de l'événement
    2012-11-19
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121119.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: greatbatch mobicath bi-directional guiding sheath medical device manufacturer, greatbatch ltd., inc., has initiated a voluntary product removal concerning mobicath bi-directional guiding sheath small curve (catalogue no.: d0140010) and mobicath bi-directional guiding sheath large curve (catalogue no.: d0140011). the manufacturer has recently observed some anomalies of the inner lumen of the mobicath sheath during the implementation of a new inspection tool during visual inspection. the anomalies may include loose, string-like liner material, line abrasion (fraying), and/or attached string-like liner material (from scratches or damage on the inner wall of sheath lumen). to date, there have been no patient injuries, or adverse events reported as a result of this issue and there have been no reported complaints of this type of defect. however, under the worst case scenario, a loose piece of the liner could be introduced into a patient during a procedure and potentially lead to a patient embolic event. for this reason, the manufacturer and the distributor decided to voluntarily recall all lots of the mobicath bi-directional guiding sheath small curve (d140010) and mobicath bi-directional guiding sheath large curve (d140011). according to the local supplier, johnson & johnson (hong kong) ltd., the affected devices were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 19 november 2012.

Device

MOBICATH Bi-Directional Guiding Sheath
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Greatbatch MOBICATH Bi-Directional Guiding Sheath
  • Manufacturer
    Greatbatch Ltd.

Manufacturer

Greatbatch Ltd.