Events

Alerte De Sécurité sur Imager II Angiographic Catheter

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

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
    2016-12-21
  • Date de publication de l'événement
    2016-12-21
  • 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_20161221b.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: boston scientific imager ii angiographic catheter medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its imager ii angiographic catheter. the details of the affected device are as follows:- material number (upn): m001316581 (5-pack outer package upn); m001316580 (single unit, inner package upn); lot/batch number: 00116127; expiration date: september 30, 2018] the manufacturer is initiating a voluntary removal of a single lot of imager ii angiographic catheters due to packaging mislabeling. after receiving one complaint from the field, the manufacturer determined that one lot of product was labeled as imager ii contra 2 curve catheters, when in fact it contained contra curve catheters. the curve discrepancy is easily detected by users and the device can be readily exchanged resulting in an insignificant prolongation in procedure. there have been no reports of patient injury. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 december 2016.

Device

Imager II Angiographic Catheter
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Boston Scientific Imager II Angiographic Catheter
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH