Events

Alerta De Seguridad para Soluset 100 Burette IV Set

Según Food and Drug Administration Philippines, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Philippines que fue producido por Hospira de Costa Rica Ltd..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Número del evento
    2014-046
  • País del evento
    Philippines
  • Fuente del evento
    FDAP
  • URL de la fuente del evento
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/164059-fda-advisory-no-2014-046
  • Notas / Alertas
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, 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 recall data from the U.S. and Philippines.
  • Notas adicionales en la data
  • Causa
    Fda advisory no. 2014-046 lifting of the quality hold in soluset 100 burette intravenous iv set imported by hospira philippines inc on 04 november 2013, fda advisory no. 2013-048; quality hold on soluset 100 burette iv (intravenous) set imported by hospira philippines inc was issued to conduct quality check. testing was conducted by the laboratory unit of food and drug administration on 09 december 2013 on 18 sets of soluset burette intravenous (iv) set batch number 170785g. the test has a satisfactory result and passed the sterility test.  a seperate investigation was conducted by hospira philippines, on all the remaining stocks of soluset tm burette intravenous (iv) set. historical complaints search, review of the batch record, evaluation of the inspection results of visual checking and physical evaluation of the two lot numbers invloves were conducted by the company. this resulted to no discrepancies that may have contributed to the complaint are improper use of hairnet and gowning during the coiling, packaging or sealing process. the qa/production management personnel of hospira were notified. proper gowning and wearing of hairnet was implemented in the clean room to mitigate this kind of problem from occurring. in this regard, the quality hold on solucet tm burette intravenous (iv) set imported by hospira philippines inc. with batch number 170145g and 170785g is hereby lifted effective immediately. hospira philippines inc can now sell the products       attachments: fa2014-046.Pdf.

Device

Soluset 100 Burette IV Set

Manufacturer

Hospira de Costa Rica Ltd.
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    FDAP