Events

Alerte De Sécurité sur Hickman and Leonard Central Venous Catheter kits

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

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
    2016-04-07
  • Date de publication de l'événement
    2016-04-07
  • 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_20160407.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: bard hickman and leonard central venous catheter kits medical device manufacturer, bard access systems, inc., has issued a medical device safety alert concerning its hickman and leonard central venous catheter kits. the affected product code numbers are as follows: code numbers: 1) 0600560 ; 2) 0600564; 3) 0600580; 4) 0600600; 5) 0600604; 6) 0600620; 7) 0600630; 8) 0600634; 9) 0600650; 10) 0600654; 11) 0606560; 12) 0606564 the manufacturer became aware that an incorrect expiration period was assigned for the introducer needle of three lots included in various central venous catheter products (hickman and leonard catheters). a 15 year expiration period was assigned to the needle lots when the actual expiration period should have been about 5 years. according to the manufacturer’s health hazard evaluation report, this issue is unlikely to pose an incremental risk of harm. the manufacturer advises affected users to refer to the field safety notice (fsn) for the proper expiration date of the kit due to the needle. this notification does not impact any consumed product or patients with these catheters implanted. the product can be used with the understanding of the correct expiration date mentioned in the fsn. 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 7 april 2016.

Device

Hickman and Leonard Central Venous Catheter kits
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Bard Hickman and Leonard Central Venous Catheter kits
  • Manufacturer
    Bard Access Systems

Manufacturer

Bard Access Systems