【转】FDA发布气管切开插管一级召回令

蓝鱼o_0

FDA发布气管切开插管一级召回令

2012年2月25日，FDA发布一项有关气管切开插管的一级召回令，这是FDA最高级别的召回令，意味着有患者可能会因此受伤或死亡。

FDA公布这些插管的生产商为英国Smiths医疗国际有限公司，注册商标为Bivona（点击查看涉事插管的产品批次）。有报告称在移除这些涉事插管附件时，需要额外加力，有时甚至无法拔出，这有可能会导致患者受伤或死亡。在某些情况下，用力拔出插管时，会导致松脱现象。此时患者往往需要紧急更换插管。

FDA表示使用者需要鉴别目前正在使用的插管，避免使用涉事插管并更换为未受影响的产品。通常情况下，这些产品常在卫生保健结构或家庭中使用。

Trach Tube Recall Raised to Highest Level

wmr

FDA发布一项有关气管切开插管的一级召回令，这是FDA最高级别的召回令，意味着有患者可能会因此受伤或死亡。该产品不知在中国有销售多少？

蓝鱼o_0

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Smiths Medical Issues Urgent Device Recall
of Certain Bivona® Neonatal, Pediatric,
and Flextend Tracheostomy
Tubes

Contact:
Consumer:
866-216-8806
bivona.tr3@smiths-medical.com

Media:
Judith Rossi
Smiths Medical
781-792-2539

FOR IMMEDIATE RELEASE - December 22, 2011 - Smiths Medical, a leading global medical device manufacturer, announced today that it is initiating a nationwide voluntary recall of Bivona® Neonatal, Pediatric and FlexTend™ Tracheostomy Tubes with integrated connector which is not designed to be used with a disconnect wedge. The FDA has been apprised of this action.

Smiths Medical is conducting this recall because some customers have experienced difficulty disconnecting accessories from the connectors of the Affected Tubes. In some cases, the customer was unable to disconnect the accessory or excessive force led to decannulation of the tube, and an emergency tracheostomy tube change was required. If the accessory is correctly connected to the Affected Tubes, then there will be no issue with disconnection. A copy of the customer notification letter, along with pictures to distinguish the affected tubes, is posted on the Smiths Medical website at http://www.smiths-medical.com.

Consumers who have the Affected Tubes should:

• Identify all affected unused product in inventory and segregate it to a quarantine location.
  Complete the Confirmation Form located at http://www.smiths-medical.com1 and return it by Fax to 219-989-7259 or by email to bivona.tr3@smiths-medical.com.
• Upon receipt of your completed Confirmation Form, Customer Service will contact you with a Return Material Authorization Number (RMA#), and will schedule the shipment of a replacement Bivona® Neonatal, Pediatric and FlexTend™ Tracheostomy Tube. If you are opting to return the product, credit will be issued upon receipt of the returned product.
  

If an Affected Tube is currently in use with a patient, there is no evidence to suggest that immediate removal of the Tracheostomy Tube is necessary. Please visit Smiths Medical’s website at http://www.smiths-medical.com/education-resources/videos/airway/index.html2 for a video demonstration on how to properly connect and disconnect accessories from the Affected Tubes.

Details of Affected Devices:
Bivona® Neonatal, Pediatric and FlexTend™ Tracheostomy Tubes
Lot Numbers 1631477 through 1923406
Reorder Numbers

Reorder Number	Product Name	Size
60NFP40	Bivona® Uncuffed Neonatal FlexTend™ Plus Tracheostomy Tube	4.5
60NFPS25	Bivona® Uncuffed Neonatal FlexTend™ Plus Tracheostomy Tube	2.5
60NFPS30	Bivona® Uncuffed Neonatal FlexTend™ Plus Tracheostomy Tube	3.0
60NFPS35	Bivona® Uncuffed Neonatal FlexTend™ Plus Tracheostomy Tube	3.5
60NFPS40	Bivona® Uncuffed Neonatal FlexTend™ Plus Tracheostomy Tube	4.0
60P025	Bivona® Uncuffed Pediatric Tracheostomy Tube	2.5
60P030	Bivona® Uncuffed Pediatric Tracheostomy Tube	3.0
60P035	Bivona® Uncuffed Pediatric Tracheostomy Tube	3.5
60P040	Bivona® Uncuffed Pediatric Tracheostomy Tube	4.0
60P045	Bivona® Uncuffed Pediatric Tracheostomy Tube	4.5
60P050	Bivona® Uncuffed Pediatric Tracheostomy Tube	5.0
60P055	Bivona® Uncuffed Pediatric Tracheostomy Tube	5.5
60PFP40	Bivona® Uncuffed Pediatric FlexTend™ Plus Extra Length Tracheostomy Tube	4.0
60PFP45	Bivona® Uncuffed Pediatric FlexTend™ Plus Extra Length Tracheostomy Tube	4.5
60PFP50	Bivona® Uncuffed Pediatric FlexTend™ Plus Extra Length Tracheostomy Tube	5.0
60PFP55	Bivona® Uncuffed Pediatric FlexTend™ Plus Extra Length Tracheostomy Tube	5.5
60PFP60	Bivona® Uncuffed Pediatric FlexTend™ Plus Extra Length Tracheostomy Tube	6.0
60PFPS40	Bivona® Uncuffed Pediatric FlexTend™ Plus Extra Length Tracheostomy Tube	4.0
60PFPS45	Bivona® Uncuffed Pediatric FlexTend™ Plus Extra Length Tracheostomy Tube	4.5
60PFPS50	Bivona® Uncuffed Pediatric FlexTend™ Plus Extra Length Tracheostomy Tube	5.0
60PFPS55	Bivona® Uncuffed Pediatric FlexTend™ Plus Extra Length Tracheostomy Tube	5.5
60PFPS60	Bivona® Uncuffed Pediatric FlexTend™ Plus Extra Length Tracheostomy Tube	6.0
60PFS25	Bivona® Uncuffed Pediatric FlexTend™ Plus Standard Tracheostomy Tube	2.5
60PFS30	Bivona® Uncuffed Pediatric FlexTend™ Plus Standard Tracheostomy Tube	3.0
60PFS35	Bivona® Uncuffed Pediatric FlexTend™ Plus Standard Tracheostomy Tube	3.5
60PFS40	Bivona® Uncuffed Pediatric FlexTend™ Plus Standard Tracheostomy Tube	4.0
60PFS45	Bivona® Uncuffed Pediatric FlexTend™ Plus Standard Tracheostomy Tube	4.5
60PFS50	Bivona® Uncuffed Pediatric FlexTend™ Plus Standard Tracheostomy Tube	5.0
60PFS55	Bivona® Uncuffed Pediatric FlexTend™ Plus Standard Tracheostomy Tube	5.5
60PFSS25	Bivona® Uncuffed Pediatric FlexTend™ Plus Standard Tracheostomy Tube	2.5
60PFSS30	Bivona® Uncuffed Pediatric FlexTend™ Plus Standard Tracheostomy Tube	3.0
60PFSS35	Bivona® Uncuffed Pediatric FlexTend™ Plus Standard Tracheostomy Tube	3.5
60PFSS40	Bivona® Uncuffed Pediatric FlexTend™ Plus Standard Tracheostomy Tube	4.0
60PFSS45	Bivona® Uncuffed Pediatric FlexTend™ Plus Standard Tracheostomy Tube	4.5
60PFSS50	Bivona® Uncuffed Pediatric FlexTend™ Plus Standard Tracheostomy Tube	5.0
60PFSS55	Bivona® Uncuffed Pediatric FlexTend™ Plus Standard Tracheostomy Tube	5.5
60SN025	Bivona® Uncuffed Neonatal Tracheostomy Tube	2.5
60SN030	Bivona® Uncuffed Neonatal Tracheostomy Tube	3.0
60SN035	Bivona® Uncuffed Neonatal Tracheostomy Tube	3.5
60SN040	Bivona® Uncuffed Neonatal Tracheostomy Tube	4.0
60SP025	Bivona® Uncuffed Neonatal Tracheostomy Tube	2.5
60SP030	Bivona® Uncuffed Neonatal Tracheostomy Tube	3.0
60SP035	Bivona® Uncuffed Neonatal Tracheostomy Tube	3.5
60SP040	Bivona® Uncuffed Neonatal Tracheostomy Tube	4.0
60SP045	Bivona® Uncuffed Neonatal Tracheostomy Tube	4.5
60SP050	Bivona® Uncuffed Neonatal Tracheostomy Tube	5.0
60SP055	Bivona® Uncuffed Neonatal Tracheostomy Tube	5.5
65N025	Bivona® Aire-Cuf® Neonatal Tracheostomy Tube	2.5
65N030	Bivona® Aire-Cuf® Neonatal Tracheostomy Tube	3.0
65N035	Bivona® Aire-Cuf® Neonatal Tracheostomy Tube	3.5
65N040	Bivona® Aire-Cuf® Neonatal Tracheostomy Tube	4.0
65N025	Bivona® Aire-Cuf® Neonatal Tracheostomy Tube	2.5
65P030	Bivona® Aire-Cuf® Pediatric Tracheostomy Tube	3.0
65P035	Bivona® Aire-Cuf® Pediatric Tracheostomy Tube	3.5
65P040	Bivona® Aire-Cuf® Pediatric Tracheostomy Tube	4.0
65P045	Bivona® Aire-Cuf® Pediatric Tracheostomy Tube	4.5
65P050	Bivona® Aire-Cuf® Pediatric Tracheostomy Tube	50
65P055	Bivona® Aire-Cuf® Pediatric Tracheostomy Tube	5.5
65SN025	Bivona® Aire-Cuf® Pediatric Tracheostomy Tube	2.5
65SN030	Bivona® Aire-Cuf® Pediatric Tracheostomy Tube	3.0
65SN035	Bivona® Aire-Cuf® Pediatric Tracheostomy Tube	3.5
65SN040	Bivona® Aire-Cuf® Pediatric Tracheostomy Tube	4.0
65SP025	Bivona® Aire-Cuf® Pediatric Tracheostomy Tube	2.5
65SP030	Bivona® Aire-Cuf® Pediatric Tracheostomy Tube	3.0
65SP035	Bivona® Aire-Cuf® Pediatric Tracheostomy Tube	3.5
65SP040	Bivona® Aire-Cuf® Pediatric Tracheostomy Tube	4.0
65SP045	Bivona® Aire-Cuf® Pediatric Tracheostomy Tube	4.5
65SP050	Bivona® Aire-Cuf® Pediatric Tracheostomy Tube	5.0
65SP055	Bivona® Aire-Cuf® Pediatric Tracheostomy Tube	5.5
67N025	Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube	2.5
67N030	Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube	3.0
67N035	Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube	3.5
167N040	Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube	4.0
67P025	Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube	2.5
67P030	Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube	3.0
67P035	Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube	3.5
67P040	Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube	4.0
67P045	Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube	4.5
67P050	Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube	5.0
67P055	Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube	5.5
67SN025	Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube	2.5
67SN030	Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube	3.0
67SN035	Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube	3.5
67SN040	Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube	4.0
67SP025	Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube	2.5
67SP030	Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube	3.0
67SP035	Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube	3.5
67SP040	Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube	4.0
67SP045	Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube	4.5
67SP050	Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube	5.0
67SP055	Bivona® TTS™ Cuffed Pediatric Tracheostomy Tube	5.5

Smiths Medical is notifying its customers through the U.S. mail. Recipients of the Urgent Field Safety Notice who have distributed the Affected Tubes to other persons or facilities should promptly forward a copy of the Urgent Field Safety Notice accordingly.
For questions regarding this Recall, customers should contact:

Smiths Medical Customer Service (Monday – Friday 8am – 8pm CST)
800-258-5361, Option 1
bivona.tr3@smiths-medical.com

Customers should report any issues with the Bivona® Neonatal, Pediatric and FlexTend Tracheostomy Tubes to Smiths Medical’s Complaints Department at 1-866-216-8806.
Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online at www.fda.gov/MedWatch/report.htm3 Regular Mail; use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm4
• Fax 1-800-FDA-0178.
  

About Smiths Medical
Smiths Medical www.smiths-medical.com is a leading supplier of specialized medical devices and equipment for global markets, focusing on the medication delivery, vital care and safety devices market segments. It is part of Smiths Group www.smiths.com, a global leader in applying advanced technologies for markets in threat and contraband detection, energy, medical devices, communications and engineered components. Smiths Group employs around 22,000 people in more than 50 countries

心语心愿

我院曾用过此品牌的气管插管，但不知是否是这些批号，以通知相关人员核查。谢谢提醒！good  night!

树叶儿

不懂外语，所以看了也等于没有看。哪位老师可以翻译一下品牌？谢谢！

toto

2012年2月25日，FDA发布一项有关气管切开插管的一级召回令，这是FDA最高级别的召回令，意味着有患者可能会因此受伤或死亡。

FDA公布这些插管的生产商为英国Smiths医疗国际有限公司，注册商标为Bivona（点击查看涉事插管的产品批次）。有报告称在移除这些涉事插管附件时，需要额外加力，有时甚至无法拔出，这有可能会导致患者受伤或死亡。在某些情况下，用力拔出插管时，会导致松脱现象。此时患者往往需要紧急更换插管。

FDA表示使用者需要鉴别目前正在使用的插管，避免使用涉事插管并更换为未受影响的产品。通常情况下，这些产品常在卫生保健结构或家庭中使用。

蓝鱼o_0

scgyygy 发表于 2012-2-28 23:59

                               
登录/注册后可看大图

不懂外语，所以看了也等于没有看。哪位老师可以翻译一下品牌？谢谢！

国外的商品都是英文名啊。这个翻译应该没什么用吧。

男丁格尔

比较恐怖的事情。。。貌似国内也有用这个牌子啊！

沉静之心

谢谢老师提醒，但我院好像没有使用英国的产品样？我倒是应该去查查哈！