Events

KNIFE KNEE FOR TRACHEOSTOMY WITH SHILEY BALLOON (Anvisa Registry n ° 10139810076). List of affected products available at http://portal.anvisa.gov.br/wps/wcm/connect/aff6ed80422df0209b12ff01cce3dc94/Lista+de+Produtos+Afetados.pdf?MOD=AJPERES 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 MALLINCKRODT DO BRASIL LTDA.; Covidien. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    1016
  • 날짜
    2010-04-19
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Abroad, some of the manufacturer's clients reported serious adverse events, which may be related to Shiley cuff tracheostomy tubes - the cuff does not retain leaking air in the inflation envelope of the pilot balloon. The codes affected by the recall in the Brazilian market are listed in the Product Description field of this alert. Batch numbers are formed by the sequence AAMMXXXXXX, where AA is the year, MM is the month, and XXXXXX is a sequential number.
  • 원인
    The cuff of the tracheostomy tube does not retain air from leaks in the pilot balloon inflation set. if the cuff does not retain air, ventilation is adversely affected and immediate tube replacement may be necessary for tracheostomy.
  • 조치
    The product registration holder in Brazil is collecting the affected lot numbers from Shiley Tracheostomy Products. Product users should check their inventory and separate any product from the batch numbers that have been affected. Affected products that have not yet been used should be returned according to the instructions given below: If a Shiley cuff tracheostomy tube of one of the affected batches is already being used in a patient, it is recommended that the tube be replaced by a tube of some lot that has not been affected, so the doctor responsible for the patient judges clinically appropriate. If the physician advises that the tracheostomy tube is maintained until there is a more acceptable replacement opportunity, it is strongly recommended that the frequency and intensity of monitoring of the cuff inflation system be increased. To return the affected product and obtain refund, you must contact Covidien's Customer Service department at 0800-1780170 or email atendimento.brasil@covidien.com. If the product was purchased from a distributor, the user should contact their supplier to follow the due return procedure. Companies that have distributed products whose codes are listed to other persons or units should immediately forward a copy of this notice to such persons or units. To check the codes and batches of the affected products, access http://portal.anvisa.gov.br/wps/connect/aff6ed80422df0209b12ff01cce3dc94/Lista+de+Produtos+Afetados.pdf?MOD=AJPERES

Device

KNIFE KNEE FOR TRACHEOSTOMY WITH SHILEY BALLOON (Anvisa Registry n ° 10139810076). List of affect...

Manufacturer

MALLINCKRODT DO BRASIL LTDA.; Covidien.