Events

Alerte De Sécurité sur Vital-Port Vascular Access Systems

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Cook Medical.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2017-12-05
  • Date de publication de l'événement
    2017-12-05
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20171205.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: cook medical vital-port vascular access systems medical device manufacturer, cook medical, has issued a medical device safety alert concerning its vital-port vascular access systems (vital-port). the affected devices are:- vital-port vascular access system titanium power injectable single-chamber systems catalogue identifier: ip-7110, ip-s7010, ip-s7110, ip-s9010, ip-s9110; gpn: g20254, g26434, g26436, g26438, g26440; all lots vital-port vascular access system standard, petite and mini titanium and mri single-chamber systems catalogue identifier: ip-5112-n, ip-5112-nc, ip-5116, ip-5116-n, ip-5118-n, ip-5118-nc, ip-6018, ip-6113, ip-7112, ip-9112, ip-s5016, ip-s5018, ip-s5116, ip-s5116-mpis-nt, ip-s5116-n, ip-s5116w, ip-s5116w-mpis-nt, ip-s5118, ip-s5118-n, ip-s6010, ip-s6012, ip-s6013, ip-s6018, ip-s6110, ip-s6112, ip-s6113, ip-s6113-mpis-nt, ip-s6118, ip-s6118-mpis-nt, ip-s7012, ip-s7112, ip-s9012, ip-s9112; gpn: g46543, g26539, g26468, g46544, g46545, g26540, g26510, g26424, g19803, g19769, g26469, g26507, g26470, g50864, g46546, g26472, g26489, g26509, g46547, g26430, g26458, g26431, g26511, g26432, g26449, g26433, g50860, g26513, g50861, g26435, g26437, g26439, g26441; all lots vital-port vascular access system standard and petite titanium dual-chamber systems catalogue identifier: ip-s1021, ip-s1121, ip-s7029, ip-s7129, ip-s7129-mpis-nt; gpn: g26428, g26429, g26502, g26504, g50863; all lots the manufacturer is initiating a voluntary recall of the products listed above. during testing of the non-coring needle, the manufacturer has identified that the non-coring needle provided with the cook vital-port may cut or dislodge a core or sliver of material from the vital-port septum when the non-coring needle is inserted into the vital-port. this needle is used on the initial implant of the vital-port. vital-port products that have been successfully placed in patients are not impacted by this recall. according to the manufacturer, potential adverse events that may occur are unwanted side effects from silicone cores or slivers that may embolise into the patients’ bloodstream. in addition, medications may leak from the port, resulting in inadequate delivery of the medication and potential injury to the surrounding tissues. there have been no adverse event reports from septum leakage or a silicone sliver pushed into the patient associated with these products to date. the manufacturer is advising users to examine inventory immediately to determine if they have affected products and quarantine affected products. product recall is on-going. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 5 december 2017.

Device

Vital-Port Vascular Access Systems
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Cook Medical Vital-Port Vascular Access Systems
  • Manufacturer
    Cook Medical

Manufacturer

Cook Medical