Events

Alerte De Sécurité sur BD Eclipse Needle

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

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
    2017-01-11
  • Date de publication de l'événement
    2017-01-11
  • 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_20170111.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: 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
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: BD Eclipse Needle
  • Manufacturer
    BD

Manufacturer

BD