Events

Alerte De Sécurité sur Select 3D and Select CAP Arterial Cannula

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

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
    2014-02-11
  • Date de publication de l'événement
    2014-02-11
  • 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_20140211b.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: medtronic select 3d and select cap arterial cannula the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning all models of select 3d and select cap arterial cannula product families manufactured by medtronic due to reports of the cannula body splitting near the suture collar.. the affected model numbers are 78618, 78620, 78622, 78624, 78718, 78720, 78722, cb78722, 78724, 78818, 78820, 78822, 78920, 78922, 78924, 3y90r3 and c300901b. since january 2012, the manufacturer has received nine such reported events which represent a 0.06% occurrence rate. of these, one was associated with a patient death and one other was associated with serious injury. according to the manufacturer, potential patient harms resulting from this type of splitting may include: the delivery of inadequate blood flow, possibly resulting in ischemia or inadequate perfusion. difficulty in inserting/removing the cannula tip, possibly resulting in a procedural delay, vessel damage, dissection or other complications that may contribute to patient death. the manufacturer advises users to identify and quarantine all affected products and return them to the manufacturer. for details, please refer to the following link:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con371783 according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 11 february 2014.

Device

Select 3D and Select CAP Arterial Cannula
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Medtronic Select 3D and Select CAP Arterial Cannula
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH