Events

Field Safety Notices about Vital Port Vascular Access System Tip: Petite Titanium; Mini Titanium; Petite Dual; Standard M.R.I, Petite M.R.I; Standard Titanium Power Injectable Port

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by Cook Incorporated.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2017-11-29
  • Event Date Posted
    2018-01-31
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2018/01/31/obavestenje-o-meri-povlacenja-sa-trzista-medicinskog-sredstva-vital-port-vascular-access-system-tip-petite-titanium-mini-titanium-petite-dual-standard-m-r-i-petite-m-r-i-standard-titanium-power/
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 recall data from the U.S. and Serbia.
  • Extra notes in the data
  • Reason
    During non-coring needle testing, it was observed that the non-coring needle provided with the cook vital-port vascular access system (vital-port) could cut or tear off the core or tear off a small portion of the material from the vital-port "of the septum, when the non-coring needle is inserted into the" vital-port ". this non-coring needle is used for the initial implantation of vital-port. potential adverse events that may occur may occur from silicone nuclei or particles that can embolize into the patient's bloodstream. additionally, drugs can leak out of the port, resulting in inadequate drug delivery and potential injury to surrounding tissues.Ports that have been successfully implanted are not covered by this withdrawal.

Device

Vital Port Vascular Access System Tip: Petite Titanium; Mini Titanium; Petite Dual; Standard M.R....

Manufacturer

Cook Incorporated