Events

Alerte De Sécurité sur BioPath 035

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

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
    2015-02-23
  • Date de publication de l'événement
    2015-02-23
  • 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_20150223d.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: biosensors international biopath 035 medical device manufacturer, biosensors international, has issued a field safety notice concerning biopath 035, with the following details: model bpth-35-60100l (balloon diameter 6.0 x 100mm length – catheter length 135cm) all lot numbers for this model manufactured prior to november 2014 are affected. the manufacturer has received a report regarding a compatibility issue with the recommended sheath introducer size. the product is currently labelled for a 5f sheath introducer compatibility when the product specification is indicating a 6f recommendation. according to the manufacturer, this mislabeling has no impact on patient safety but it may lead to a prolonged procedure. patients who have already been successfully treated with an affected device are not impacted by this action. the manufacturer advises users to identify and quarantine the affected products. they will contact the affected users to arrange the corrective action. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 february 2015.

Device

BioPath 035
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Biosensors International BioPath 035
  • Manufacturer
    Biosensors International

Manufacturer

Biosensors International