Events

Alerte De Sécurité sur Nonvented Y-Set

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

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
    2014-04-17
  • Date de publication de l'événement
    2014-04-17
  • 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_20140417.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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: hospira nonvented y-set medical device manufacturer, hospira, has issued a medical device safety alert concerning its nonvented y-set for transurethral resection (list number: 06543-01). the impacted batches are 13106ns, 13170ns, 13251ns, 14261ns, 14262ns, 15139ns, 16117ns, 17131ns, 17132ns, 17184ns, 18110ns, 18111ns, 18182ns, 19133ns, 20122ns, 20123ns, 20124ns, 20205ns, 22146ns, 22147ns, 22148ns, 22149ns, 23103ns, 23104ns, 23105ns, 23106ns, 24156ns, 25130ns, 25131ns, 27109ns, 27253ns, 27286ns, 28136ns, 28137ns, 29094ns, 29095ns, 29096ns, 30194ns, 30195ns, 30196ns, 31042ns, 31043ns, 32229ns, 32230ns, 33138ns, 33139ns, 33140ns, 34286ns and 35117ns. in the complaint review, the manufacturer has discovered the issue of incomplete sealing in the secondary package of the affected batches of devices. the issue occurred either because the sterile pack was not sealed properly or the tyvek cover sheet was not centered on the bottom tray of the pack, allowing openings at the edge of the sterile package. the open packaging of the affected product may lead to loss of product sterility, delay in initiating therapy, introduction of infectious agent and particulate onto the surface of the irrigation set. up to date, the manufacturer did not receive any complaint or adverse reporting associated with the incomplete sealing of the package. the manufacturer advises affected users not to use the package if it is not intact. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 april 2014.

Device

Nonvented Y-Set
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Hospira Nonvented Y-Set
  • Manufacturer
    Hospira

Manufacturer

Hospira
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    DH