Events

Alerta De Seguridad para BD Eclipse Needle

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por BD.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2017-01-11
  • Fecha de publicación del evento
    2017-01-11
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170111.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: bd eclipse needle medical device manufacturer, bd, has issued a medical device safety alert concerning its eclipse needle. (catalogue numbers: 302811, 302812, 302813, 302814, 302815, 302816, 302817, 302818, 305757, 305758, 305759, 305761, 305762, 305763, 305764, 305765, 305766, 305767, 305768, 305769, 305775, 305776, 305778, 305779, 305780, 305781, 305782, 305783, 305784, 305785, 305786, 305787, 305788, 305789, 305790, 305791, 305792, 305793, 305794, 305795, 305796, 305797, 364389, 364390, 364391, 364393, 365059, 365061, 30281864, 30281364, 30281464, 30281564, 30281664, 30281764, 30281864) the manufacturer has received reports of safety cover disengagement and needlestick injury (nsi) for the bd eclipse needle.. some customer reports indicate an audible “click” sound before the safety cover is locked (activated) followed by a second “click” sound when the safety cover is locked over the needle. this may potentially increase the risk of nsi if the user assumes the safety cover is locked after the initial “click”. the manufacturer advises customers to be aware of this matter and follow the instructions for use. the manufacturer is actively working on implementing corrective actions. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 january 2017.

Device

BD Eclipse Needle
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: BD Eclipse Needle
  • Manufacturer
    BD

Manufacturer

BD