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.
Smiths Medical於2024年5月29日發佈了緊急的醫療器械通知，通知受影響的客戶可能存在某些Bivona氣管切開管的潛在問題。
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.
所有受影響的客戶和經銷商都會收到一封信，概述風險並提供特定步驟來判斷他們的設備是否受影響，以及如何處理受影響的產品。可以從ICU醫療公司的網站上訪問該信件的副本以及受影響產品的列表。
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日發送給客戶的通知指出，如果物品上的凸緣破裂或損壞，氣管切開管可能無法保持在氣管位置。這可能導致氣管切開位置移位或脫管。這兩種事件都可能導致無法正確通氣或保護氣道並可能對致命的不良事件做出貢獻。
For further inquiries, please contact Smiths Medical using the information provided below.
如有任何進一步的問題，請使用以下提供的信息聯繫Smiths Medical。
|
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 |
|
Smiths醫療聯繫人 |
聯繫信息 |
支持領域 |
|
全球投訴管理 |
[email protected] 1-(866)-216-8806 |
報告不良事件或 |
|
客戶服務 |
[email protected] 1-(800)-259-5361 |
有關您的產品的問題以及/或更換 |
The U.S. Food and Drug Administration (FDA) has been notified of this action.
美國食品藥品監督管理局（FDA）已被通知此行動。
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.
使用此產品時經歷的不良反應或質量問題可以通過FDA的MedWatch不良事件報告計劃在線、通過常規郵件或傳真報告。
- 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
- 完成和提交報告在線版：
- 常規郵件或傳真：下載表格或致電1-800-332-1088索取報告表格，然後填寫並將其退回到預先填寫地址的表格上或通過傳真提交到1-800-FDA-0178
Media Contact:
Harrison Richards
949-366-4261
[email protected]
媒體聯繫人：
哈里森·理查茲
949-366-4261
[email protected]
SOURCE Smiths Medical
消息來源：Smiths Medical
譯文內容由第三人軟體翻譯。