Events

Safety Alert for 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;

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by B Braun Medical Inc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    550
  • Date
    2002-03-01
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    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