Events

Rappel de Bard BrachySource Seed Implants

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 Bard Brachytherapy, 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
    79972
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1702-2018
  • Date de mise en oeuvre de l'événement
    2018-04-10
  • Date de publication de l'événement
    2018-04-27
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164063
  • 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
    Source, brachytherapy, radionuclide - Product Code KXK
  • Cause
    Bard medical division is recalling the bard¿ brachysource¿ iodine125 radioactive seeds in mick¿ applicators and bard¿ brachysource¿ iodine125 radioactive seeds loose in vial with sterile spacers. because the incorrect dosage level radioactive seeds were mixed up and sent to two hospitals. one hospital ordered brachysource¿ iodine125 0.36 mci radioactive seeds but instead received brachysource¿ iodine125 0.28 mci radioactive seeds and vice versa for the other hospital affected.
  • Action
    The notification to the customer was completed by Bard Medical Customer Service via a telephone call to alert them of the incorrect product shipped on April 10, 2018. Bard Medical Division is recalling the BARD¿ BrachySource¿ Iodine125 Radioactive Seeds in Mick¿ Applicators and BARD¿ BrachySource¿ Iodine125 Radioactive Seeds Loose in Vial with Sterile Spacers. The incorrect dosage level of radioactive seeds was sent to 2 hospitals. One hospital ordered 0.36 mCi radioactive seeds but instead received 0.28 mCi radioactive seeds intended for the other hospital. For further questions, please call (770) 385-0562.

Device

Bard BrachySource Seed Implants
  • Modèle / numéro de série
    Product Code:1251CSR, BrachySource¿ Seed Implants in Re-Usable Mick¿ Applicators (60 seeds at 0.28mCi) with Lot BBCP0079  Product Code: 1251CSRA, BrachySource¿ Seed Implants in Shielded Mick¿ Applicators (10 seeds at 0.28mCi) with Lot BBCQ0026  Product Code: PS1251LS, Loose BrachySource¿ Seed Implants (with Lot BBCQ0050) Spacers (with Lot 23498276) 100 Seeds at 0.36 mCi.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution to the states of : California and Georgia
  • Description du dispositif
    BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference Figure 1 below). The I125 has a half-life of 59.6 days and decays by electron capture with the emission of characteristic photons and Auger electrons. The principal photon emissions are 27.4 and 31 keV x-rays and 35.5 keV gamma. The titanium wall of the BrachySource¿ Seed Implants absorbs the electrons.
  • Manufacturer
    Bard Brachytherapy, Inc.

Manufacturer

Bard Brachytherapy, Inc.
  • Adresse du fabricant
    Bard Brachytherapy, Inc., 295 E Lies Rd, Carol Stream IL 60188-9421
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA