Events

Rappel de BMC RF Cannula

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Baylis Medical Company Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    64250
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0879-2013
  • Date de mise en oeuvre de l'événement
    2012-10-04
  • Date de publication de l'événement
    2013-02-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-05-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115670
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Probe, radiofrequency lesion - Product Code GXI
  • Cause
    A report of an event was received indicating that upon opening a box containing 10 sterile cannula by a nurse, the pouch package of 5 of the 10 individually packaged cannula had not been sealed along one edge. thus the pouch was open and the device could fall out of the pouch and on to the floor when retrieved from the shelf box. the cannulas were not used on any patients, as the unsealed packages.
  • Action
    A recall was initiated on 10/04/2012 and a letter was sent out to the distributor with a Fax-back Acknowledgment Form. The letter described the issue and provided recommendations and a contact number.

Device

BMC RF Cannula
  • Modèle / numéro de série
    Device Model #: 1 PMF 16-145-10CS. Lot number: PFFB 190811.
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    International distribution to the country of Australia.
  • Description du dispositif
    BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white shelf-box (secondary packaging) with the instructions for use. A predetermined number of white shelf-boxes are then placed into shipping cartons (tertiary packaging). The BMC RF Cannula is intended for use in radiofrequency heat lesion procedures for relief of pain.
  • Manufacturer
    Baylis Medical Company Inc.

Manufacturer

Baylis Medical Company Inc.
  • Adresse du fabricant
    Baylis Medical Company Inc., 5160 Explorer Drive #33, Mississauga Canada Ontario
  • Société-mère du fabricant (2017)
    Baylis Medical Company, Inc
  • Source
    USFDA