Events

Avis De Sécurité sur 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

Selon ALIMS (Agencija za lekove i medicinska sredstva), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Serbia qui a été fabriqué par Cook Incorporated.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2017-11-29
  • Date de publication de l'événement
    2018-01-31
  • Pays de l'événement
    Serbia
  • Source de l'événement
    ALIMSA
  • URL de la source de l'événement
    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 / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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