Events

Rappel de Device Recall BD QSyte Luer Access Split Septum

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 Becton Dickinson & Company.

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
    70593
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1317-2015
  • Date de mise en oeuvre de l'événement
    2015-02-19
  • Date de publication de l'événement
    2015-03-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-05-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134096
  • 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
    Set, administration, intravascular - Product Code FPA
  • Cause
    Becton dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum.
  • Action
    Becton Dickinson sent an Urgent Voluntary Product Recall Letter/Recall Response Card/Packing Instructions, dated 2/19/15, to their affected customers via UPS next day mail. The letters identified the affected device and explained the reason for the recall. Customers were to review their inventory for the specific catalog and lot numbers provided and quarantine the affected product. The Recall Response Card form should be completed and faxed back to BD at 1-866-514-2113 or e-mail bd7043@stericycle.com. All affected product should be returned with the completed Recall Response Card following the steps on the enclosed packing instruction. Upon receipt of the returned product, BD will send customers replacement product. If customers have questions or require assistance, they should contact 1-866-800-2917.

Device

Device Recall BD QSyte Luer Access Split Septum
  • Modèle / numéro de série
    Lot #'s 4128925 and 4128926
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed to the states of CA, CT, FL, IL, MA, ND, NY, OH and PA.
  • Description du dispositif
    BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. || An accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids.
  • Manufacturer
    Becton Dickinson & Company

Manufacturer

Becton Dickinson & Company
  • Adresse du fabricant
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA