Events

Alerte De Sécurité sur NephroMax High Pressure Nephrostomy Balloon Catheter and NephroMax High Pressure Nephrostomy Balloon Catheter Kit

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
    2013-05-31
  • Date de publication de l'événement
    2013-05-31
  • 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_20130531.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: boston scientific nephromax high pressure nephrostomy balloon catheter and nephromax high pressure nephrostomy balloon catheter kit medical device manufacturer, boston scientific, has issued a field safety notice concerning nephromax high pressure nephrostomy balloon catheter and nephromax high pressure nephrostomy balloon catheter kit. boston scientific is conducting a recall removal of six batches of the nephromax high pressure nephrostomy balloon catheters and three batches of the nephromax high pressure nephrostomy balloon catheter kits (which are packaged with an encore 26 inflator). boston scientific has discovered that the product which is labeled to contain either a 30f x 20cm or a 24f x 17cm renal sheath may potentially contain the incorrect renal sheath size in the package. there have been five complaints received from a single batch for this issue where the product was labeled to contain a 30f x 20cm sheath but actually contained a 24f x 17cm sheath. boston scientific is aware that customers may separate the kits and store the components individually. therefore, the manufacturer advises users that when reviewing inventory, they should look for both the kit level and individual component level batch numbers. furthermore, the manufacturer advises users to immediately discontinue use of and segregate affected products, and to return the affected product. according to the local supplier, affected products were not distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 31 may 2013.

Device

NephroMax High Pressure Nephrostomy Balloon Catheter and NephroMax High Pressure Nephrostomy Ball...
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Boston Scientific NephroMax High Pressure Nephrostomy Balloon Catheter and NephroMax High Pressure Nephrostomy Balloon Catheter Kit
  • 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