Events

Alerte De Sécurité sur Reprocessed Agilis Steerable Introducer Sheath

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

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
    2018-01-04
  • Date de publication de l'événement
    2018-01-04
  • 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_20180104.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: sterilmed reprocessed agilis steerable introducer sheath the united states food and drug administration (fda) is alerting the public and health care providers that reprocessed agilis steerable introducer sheath, manufactured by sterilmed inc. the affected devices are identified as the following:- reprocessed agilis steerable introducer sheath product codes: pne; model numbers and lot numbers: stj408309, stj408310, stjg408324; all product lots; manufacturing and distribution dates: 1 january 2017 to 5 may 2017 according to the fda, the agilis steerable introducer sheath’s hemostatic valve, which prevents blood from flowing back through the valve, may fail due to an improper seal of the sheath hub. improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure, or can create a difference in pressure that allows air into the circulatory system (air embolism). the improper seal occurs when not enough glue is used to reattach the cap to the hub after reprocessing. too much glue can also block the sheath valve and make the device unusable. patients with a lower body mass index (bmi) may be more at risk if blood loss occurs. smaller patients and patients with pre-existing decreased pulmonary reserve may be more susceptible to air embolism. the use of affected products may cause serious health consequences for patients, including death. the manufacturer has provided the following instructions for health care facilities and providers: examine inventory immediately to determine if they have this product. do not use any of the affected products, and return any unused product to the company. share this information with the appropriate staff at the facility. continue to monitor patients treated with the sterilmed reprocessed agilis steerable introducer sheath as normal. for details, please refer to the fda website: https://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm590903.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 04 january 2018.

Device

Reprocessed Agilis Steerable Introducer Sheath
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Sterilmed Reprocessed Agilis Steerable Introducer Sheath
  • Manufacturer
    Sterilmed Inc

Manufacturer

Sterilmed Inc