FDA发布最高级别召回!同类产品都要注意了

医疗器械创新网 医疗器械创新网 2020-05-15
 


FDA一级召回
PythonBard
以及OTW Latis



本文摘译自FDA 2020年5月12日

以下为详文



FDA已认定这是一级召回,此为最严重的召回类型。因为使用这些设备可能会导致严重伤害或死亡。

召回产品

    Python取栓导管、Bard取栓导管和OTW Latis清洗导管


产品型号:

    Python取栓导管:A4E01,A4E02,A4E03,A4E04,A4E05,A4E06,A4E08,A4E09;

   Bard取栓导管:CE0340DR,CE0380DR,CE0440DR,CE0480DR CE0540DR,CE0580DR,CE0680DR;

      OTW Latis清洗导管:A4GW6


制造日期:2015年7月23日至2018年11月8日

发行日期:2015年8月25日至2019年3月1日

在美国召回的设备有:19,400

公司发起召回日期:2019年10月24日









设备用途

Python取栓导管、Bard取栓导管和OTW Latis清洗导管是乳胶球囊导管,用于暂时阻塞、关闭血管或输液。 


召回原因

因为Python取栓导管、Bard取栓导管和OTW Latis清洗导管在使用过程中,存在导管尖端部件脱落的风险,如果导管尖端部件脱落,其零件有可能断开,从而进入到患者的体内。


这种情况一旦发生,同样会造成严重健康后果,其中包括移除尖端部件的额外手术、血管损伤或导致死亡。


自2015年以来,已经有46起关于该设备问题的投诉。FDA已收到了三份医疗器械报告(MDRs),但无死亡或受伤的报告。 


谁可能会受到影响

    使用受影响的Python取栓导管、Bard取栓导管和OTW Latis清洗导管的医疗服务提供者

    用受影响的导管实施手术的患者








该怎么办

2019年11月8日,Applied Medical公司发出一份紧急通知——给所有受影响的客户发出《医疗器械召回函》,说明如下:


    1、请检查被召回产品的库存。

    2、填写《召回通知确认表》,确认召回,并说明您的设备是否正在退回中或已经使用了上述批次的产品。

    3、如果没有退回任何产品,请在《召回通知确认表》上注明。

    4、如果您是经销商,请通知接收到本次召回受影响产品的所有医疗机构,请同时填写《召回通知确认表》的第4页。

   5、将《召回通知确认表》以电子邮件发送至Applied Medical 10310330@appliedmedical.com或传真至949-713-8908。

    6、把受影响产品和《召回通知确认表》的副本退还给Applied Medical公司,(产品退货说明见第5页)。



联系方式

有关产品退货的联系方式:

电话:949-713-8688,或E-mail:jrios@appliedmedical.com,

联系人:客户关系部高级经理Jaclene Rios-Simpson。


有关法规的联系方式:

电话:949-713-8767,或E-mail:lcontursi@appliedmedical.com,

联系人:Lauren Contursi。


其他:

    Python取栓术召回数据库登录

    BARD取栓术召回数据库登录

    OTW Latis清洗导管召回数据库登录


如何报告?

专业医务人员和消费者可以报告他们在使用这些设备时遇到的不良反应或质量问题。请使用FDA安全性信息和不良事件报告系统(即MedWatch系统)的在线表格、常规邮件或传真等方式进行报告。






原文:



Applied Medical Recalls Python Embolectomy, BARD Embolectomy, and OTW Latis Cleaning Catheters Due to Risk of Separation During Use


The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.


Recalled Product

Python Embolectomy Catheters, Bard Embolectomy Catheters, and the OTW Latis Cleaning Catheters

Model Numbers:

Python Embolectomy Catheters: A4E01, A4E02, A4E03, A4E04, A4E05, A4E06, A4E08, A4E09

Bard Embolectomy Catheters: CE0340DR, CE0380DR , CE0440DR,CE0480DR CE0540DR, CE0580DR, CE0680DR

OTW Latis Cleaning Catheters: A4GW6

Manufacturing Dates: July 23, 2015 to November 8, 2018

Distribution Dates: August 25, 2015 to March 1, 2019

Devices Recalled in the U.S.: 19,400

Date Initiated by Firm: October 24, 2019


Device Use

The Python Embolectomy Catheters, Bard Embolectomy Catheters, and OTW Latis Cleaning Catheters are latex balloon catheters used for temporary blockage, closing of a blood vessel, or infusion of fluids. 


Reason for Recall

Applied Medical is recalling their Python Embolectomy Catheters, Bard Embolectomy Catheters, and OTW Latis Cleaning Catheters because there is a risk of the catheter tip detaching during use. If the tip detaches, pieces of the catheter could break off into the patient’s body.


If this occurs, there is also the potential for serious health consequences including additional surgical procedures to remove the tip, damage to the blood vessel, or death.


There have been 46 complaints regarding this device issue since 2015. The FDA has received three medical device reports (MDRs) and no reports of death or injury. 


Who May be Affected

Health care providers using affected Python Embolectomy, Bard Embolectomy, and the OTW Latis Cleaning Catheters

Patients undergoing procedures using affected catheters


What to Do

On November 08, 2019, Applied Medical sent an Urgent: Medical Device Recall Letter to all affected customers with the following instructions:


Check your inventory for the recalled product.

Complete the Recall Notification Confirmation Form to acknowledge the recall and indicate if your facility is returning or has already used product from the lot listed above.

If no product is being returned, please indicate on the Recall Notification Confirmation Form.

If you are a distributor, please notify all the facilities that received the affected product of this recall. Please also complete Page 4 of the Recall Notification Confirmation Form.

Return the Recall Notification Confirmation Form to Applied Medical by email to recall60810330@appliedmedical.com or by fax to 949-713-8908.

Return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical (Product Return Instructions are on Page 5).


Contact Information

For product return questions, please contact Jaclene Rios-Simpson, Senior Manager, Customer Relations at 949-713-8688 or jrios@appliedmedical.com. For regulatory questions, please contact Lauren Contursi, at 949-713-8767 or lcontursi@appliedmedical.com.


Additional Resources:

Python Embolectomy Recall Database Entry

BARD Embolectomy Recall Database Entry

OTW Latis Cleaning Catheters Recall Database Entry


How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.



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