Events

Rappel de B. Braun 13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000

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 B. Braun Medical, 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
    65356
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0425-2014
  • Date de mise en oeuvre de l'événement
    2013-04-04
  • Date de publication de l'événement
    2013-11-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-08-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118621
  • 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, i.V. Fluid transfer - Product Code LHI
  • Cause
    Possible solution leakage at the interface of the addease(tm) binary connector (product codes bc2000 and bc1300) and the pab(r) bag. based on extensive root cause investigation, it has been determined that the leakage is the result of a misaligned cannula (needle) on the addease(tm) binary connector, which pierces the pab(r) bag stopper to access the solution. the misaligned cannula may result i.
  • Action
    B Braun sent an Urgent - Medical Device Removal Notification letter dated April 4, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by he customer. Customers were instructed to review the Product Recall Notification in its entirety and ensure that all users in their organization are informed about this voluntary product recall. Determine their current inventory of the affected lots within their distribution center. Contact their customers that have received the affected lots and inform them of this voluntary product recall. Combine both their inventory, and the inventory reported by their customers, and utilize their specific "Product Removal Acknowledgement" form to record the total number of individual units (within partial cases) and the number of full-unopened cases. If no inventory remaining enter zero (0). Return the completed Acknowledgement Form to BBMI Quality Assurance in the self addressed envelope or fax to 610-849-1197. Customers should call Customer Support Department at 800-227-2862 to arrange for eturn and replacement product or for questions. For questions regarding this recall call 800-227-2862.

Device

B. Braun 13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000
  • Modèle / numéro de série
    Material BC1300, Lot number 61286479.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC1300 || Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial.
  • Manufacturer
    B. Braun Medical, Inc.

Manufacturer

B. Braun Medical, Inc.
  • Adresse du fabricant
    B. Braun Medical, Inc., 901 Marcon Boulevard, Allentown PA 18109-9512
  • Société-mère du fabricant (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA