Events

Alerte De Sécurité sur Infusion Pump, Injection Equipment: (1) Additive with Control Valve for Adult and 2 Injection Sites, (2) Adult Horizon with Check Valve and 3 Injection Sites, (3) Adult Injection Luer Lock Horizon, (4) Adult Injection Site Luer Lock, (5) Adult Vented Injection Site Luer Lock, (6) Adult VTND / 3 Injection / Luer Lock / Non-DEHP, (7) Basic, (8) Basic with 1 Injection Site, (9) Clave Additive Adult with Check Valve and 2 Injection Sites, (10) Primary Key / Additive / Horizon, (11) Horizon, (12) Horizon Non-DEHP Adult Vented, (13) Model AD150DS Vented 72-IN-PR, CSP152VSL W / Y Valve LT-FR-PR, (15) Model NF1250DO Universal Spike PR, (16) Model NF1270A SafeLine Anesthesia PR, (17) Model PB152VSL 105-IN-PR Model PB153VSL Non- (24) Model US3480 15-PR, (22) Model US3481 Sigma 15 Drop PR, (23) SafeLine Horizon Non-DEHP, (24) SafeSite (24) Model US1260 UltraSite, Horizon Pump, (25) UltraSite Horizon Pump. Number of Catalogs: (1) V1443; (2) V7410, V7410-10, V7412; (3) V7405; (4) V1415; (5) V1418; (6) V7430; (7) V1402; (8) V1482; (9) CC1270; (10) CC3130, CC3130-SP02; (11) NF3140, NF3140-10; (12) CC3150; (13) 351510; (14) 352049; (15) 352378, 352381, 352382, 352386, 352387; (16) 352359; (17) 351559, 351564, 352038; (18) 352072, 352127, 352131; (19) 375100, 474908; (20) 352393; (21) 352224, 352229, 352230, 352337, 352338, 352344, 352352, 352355, 352356; (22) 352362, 352363, 352365 to 352371, 352373, 352375, 352377; (23) NF3150; (24) SS3140; (25) US3130;

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par B Braun Medical 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
  • ID de l'événement
    550
  • Date
    2002-03-01
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    The philadelphia center for supply defense has issued a safety quality correction / alert for the above intravenous management teams. the above products are subject to removal due to loosening of the junction between the tube at the bottom of the container and the drip chamber. the manufacturer initiated a correction by letter dated october 2001, but did not provide any information to ecri.
  • Action
    Make sure you have received the letter dated October 2001 from B Braun Medical. Identify and isolate any affected product in your inventory. To combine recall of the affected product, or for more information, contact your local B Braun representative. ANVISA has provided the Occurrence Notification Forms on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

Infusion Pump, Injection Equipment: (1) Additive with Control Valve for Adult and 2 Injection Sit...

Manufacturer

B Braun Medical Inc
  • Source
    ANVSANVISA