Smiths Medical Issues Urgent Medical Device Notification Informing Customers of a Potential Issue With Certain Bivona Tracheostomy Tubes
Smiths Medical Issues Urgent Medical Device Notification Informing Customers of a Potential Issue With Certain Bivona Tracheostomy Tubes
For further inquiries, please contact Smiths Medical using the information provided below.MINNEAPOLIS, Aug. 19, 2024 /PRNewswire/ -- Smiths Medical issued an Urgent Medical Device Notification on May 29, 2024, to notify affected customers of a potential issue with certain Bivona Tracheostomy Tubes.
史密斯医疗在2024年5月29日发布了一份紧急医疗器械通知书，以通知受影响的客户，某些Bivona气管切开管存在潜在问题。
All impacted customers and distributors were sent a letter outlining the risk and providing specific steps to determine whether their devices are affected or not and what steps to follow if they have affected product in service. A copy of that letter as well as a list of affected products can be accessed on ICU Medical's website here.
所有受影响的客户和经销商都会收到一封信，列出了风险，并提供了具体步骤来判断他们的器械是否受到影响，以及如果他们使用的产品受到影响应该遵循哪些步骤。信件的副本和受影响产品的清单可在icu医疗的网站上访问。
The customer notification sent on May 29, 2024, indicated that if the flange on the item is torn or broken, the tracheostomy tube may not stay in position in the trachea. This can lead to tracheostomy displacement or decannulation. Either event may result in an inability to properly ventilate or protect the airway and may contribute to a catastrophic adverse event.
2024年5月29日发送给客户的通知指出，如果项目上的法兰裂开或破裂，气管切开管可能无法在气管中保持位置。这可能导致气管切开的移位或拔管。任何一种情况都可能导致无法正确通气或保护气道，并可能导致灾难性的不良事件的发生。
For further inquiries, please contact Smiths Medical using the information provided below.
如需进一步查询，请使用以下提供的信息联系史密斯医疗。
|
Smiths Medical Contact |
Contact Information |
Areas of Support |
|
Global Complaint Management |
[email protected] 1-(866)-216-8806 |
To report adverse events or |
|
Customer Service |
[email protected] 1-(800)-259-5361 |
Questions about your product |
|
史密斯医疗联系人 |
联系信息 |
支持领域 |
|
全球投诉管理 |
[email protected] 1-(866)-216-8806 |
报告不良事件或 |
|
客户服务 |
[email protected] 1-(800)-259-5361 |
有关您的产品的问题和/或更换 |
The U.S. Food and Drug Administration (FDA) has been notified of this action.
使用该产品出现的不良反应或质量问题可通过FDA的MedWatch不良事件报告计划进行在线、常规邮件或传真报告。
Adverse reactions or quality problems experienced with this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
在线填写并提交报告：
- Complete and submit the report Online:
- Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
- 常规邮件或传真：下载表格或致电1-800-332-1088要求报告表格，然后填写并退回预先填写地址表格上的地址，或传真至1-800-FDA-0178
- 普通邮件或传真：下载表格或致电1-800-332-1088申请报告表格，然后填写并寄到预先填写地址的表格上或传真至1-800-FDA-0178。
Media Contact:
Harrison Richards
949-366-4261
[email protected]
媒体联系人：
哈里森·理查兹
949-366-4261
[email protected]
SOURCE Smiths Medical
资料来源:史密斯医疗