Events

Alerte De Sécurité sur Entrada Needle (Accessory Infinion CX lead)

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
    2018-04-12
  • Date de publication de l'événement
    2018-04-12
  • 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_20180412b.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: entrada needle (accessory infinion cx lead) medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its entrada needle (accessory infinion cx lead). the affected devices are identified as the following: - product description: a) entrada 2.0 4.5” needle kit; b) entrada 2.0 6” needle kit; c) entrada 2.0 4.5” spare sheath kit; d) entrada 2.0 6” spare sheath kit universal product number: a) m365sc4220450; b) m365sc4220600; c) m365sc4220s450; d) m365sc4220s600 brand name: infinion cx lead approval number: 22700bzx00348000 the manufacturer has detected some products did not meet the acceptance criteria during a needle resistance loss leakage test in the accelerated 2 years aging test which was performed for an additional manufacturing site. therefore, the manufacturer is initiating voluntary removal of the products in japanese market. according to the manufacturer, if there is leakage of the products, the operator may not be able to feel sufficient resistance. this could potentially result in prolonged procedure and may puncture the spinal cord beyond the epidural space as severe health impact. however, as it is recommended that this procedure to be performed under x-ray fluoroscopy in the instruction, a severe health impact would not occur. while the product is currently being sold worldwide, there have been no complaints related to this event. the users are recommended to return unused removal products and not to use the affected products. 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 12 april 2018.

Device

Entrada Needle (Accessory Infinion CX lead)
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: "Entrada Needle (Accessory Infinion CX lead)"
  • 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