Events

Safety Alert for BARD BUTTON DEVICE DECOMPRESSION TUBES: (1 to 24) 18 FR, (1 to 24) 24 FR, (1 to 24) 28 FR; ITEMS US: (1) 000261, (2) 000262, (3) 000263, (4) 000282, (5) 000283, (6) 000284, (7) 000285, (8) 000286, (9) 000287, 000352, (15) 000352, (16) 000353, (17) 000354, (18) 000355, (19) 000356, (10) 000292, (11) 000293, (12) 20) 000357, (21) 000358, (22) 000359, (23)

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BARD INTERVENTIONAL PRODUCTS DIV C R BARD 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
    141
  • Date
    2000-09-29
  • 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 discompression tubes mentioned can be partially obstructed by fungi in the flash, causing the normal tube adapter. distributor started a correspondence removal dated of may 15, 2000.
  • Action
    MAKE SURE THAT YOU HAVE RECEIVED THE CORRESPONDENCE OF MAY 15, 2000, THE NOTICE OF REMOVAL, THE EFFECTIVENESS FORM AND A BARD INTERVENTIONAL PRODUCTS ENFORCEMENT RESPONSE, PREPAID, SEALED AND WITH THE ADDRESS OF BARD INTERVENTIONAL PRODUCTS PRINTED. IDENTIFY AND COLLECT ANY AFFECTED PRODUCT FROM YOUR INVENTORY. RETURN ALL UNUSED PRODUCTS TO BARD INTERVENTIONAL PRODUCTS BY MAIL AT THE ABOVE ADDRESS, USING THE REMOVAL RETURN AUTHORIZATION NO. 8980 (RECALL RETURN AUTHORIZATION NO 8980). SUBMIT COPIES OF REMOVAL NOTIFICATION FOR THE OPERATORS OF THE BARD, PATIENT AND CONSUMER EQUIPMENT. FILL OUT THE EFFECTIVENESS FORM AND SEND IT TO BARD INTERVENTIONAL PRODUCTS BY MAIL IN THE PRE-PAYMENT ENVELOPE. IF PATIENTS OR EMPLOYEES EXPERIENCE ANY PROBLEMS WITH GASTRIC DECOMPRESSION OR RESIDUAL EXPRESSION, DIRECT THEY TO DO THE FOLLOWING: (1) DRAIN, IRRIGATING AND ASPIRING, THE DECOMPRESSION PIPE. (2) REMOVE THE DECOMPRESSION TUBE AND EVENT WASTE FROM THE TUBE ADAPTER. (3) IRRIGATE THE DECOMPRESSION TUBE AGAIN AND REINSTALL. (4) REPLACE PATIENT TO IMPROVE DECOMPRESSION OR DISPOSAL OF GASTRIC CONTENT. (5) USE ANOTHER TUBE IF PROBLEMS PERSIST. (6) IF ANY TUBE IS REQUIRED OR IF YOU HAVE ANY QUESTIONS, PLEASE CONTACT THE CONSUMER SERVICE OF YOUR BARD INTERVENTIONAL PRODUCTS REPRESENTATIVE.

Device

BARD BUTTON DEVICE DECOMPRESSION TUBES: (1 to 24) 18 FR, (1 to 24) 24 FR, (1 to 24) 28 FR; ITEMS ...

Manufacturer

BARD INTERVENTIONAL PRODUCTS DIV C R BARD INC
  • Source
    ANVSANVISA