Events

Alerte De Sécurité sur TruGuide Disposable Coaxial Biopsy Needles

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 Peripheral Vascular.

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
    2016-02-15
  • Date de publication de l'événement
    2016-02-15
  • 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_20160215.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 truguide disposable coaxial biopsy needles medical device manufacturer, bard peripheral vascular, inc., has issued a medical device safety alert concerning its bard truguide disposable coaxial biopsy needles [part number: c2016b, lot numbers: rewl0924, rexa1695, rexb1529, rexc1632]. the manufacturer has confirmed that the product code/ lot number combination listed above may be at risk of having an incorrectly sized blunt tip stylet within its packaging that will not pass through the coaxial. specifically, the product should contain a 19 gauge blunt tip stylet when the actual packaged product contains a 17 gauge blunt tip stylet. according to the manufacturer, the potential hazard associated with attempting to proceed in the placement of the coaxial utilising the sharp trocar stylet, instead of the intended optional blunt tip stylet, may be variable depending on the anatomical location of the biopsy and may pose an incremental risk of unintended injury to tissue, vasculature, or other organs. if the affected device has already been safely used, then no further product related action is required. product recall is on-going. 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 15 february 2016.

Device

TruGuide Disposable Coaxial Biopsy Needles
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Bard TruGuide Disposable Coaxial Biopsy Needles
  • Manufacturer
    Bard Peripheral Vascular

Manufacturer

Bard Peripheral Vascular