3M Deutschland GmbH Carl-Schurz-Straße 1 41453 Neuss

3M Deutschland GmbH
Carl-Schurz-Straße 1
41453 Neuss
GERMANY
+49 (0)2131/140
+49 (0)2131/142649
Internet: www.3M.de
E-Mail: [email protected]
WEEE-Reg.-Nr. DE 36963167
VAT-ID: DE 120679179
Field Safety Notice
Name of the affected product: 3M™ Tegaderm PICC CVC Securement Device + CHG I.V. Securement
Dressing (Reference Code 1877-2100 and 1879-2100)
FSCA-identifier: FSN 2017-02 FSCA Tegaderm PICC CVC
Type of action: Isolation and disposure of the device
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Date: February 1 , 2017
Attention: 3M Customers
3M is conducting a Field Safety Corrective Action (FSCA) for 3M™ Tegaderm PICC CVC Securement Device +
CHG I.V. Securement Dressing (Reference Codes 1877-2100 and 1879-2100).
Details on affected devices:
The following product is in scope of this FSCA:
Product name
3M™ Tegaderm PICC CVC Securement Device
+ CHG I.V. Securement Dressing
3M™ Tegaderm PICC CVC Securement Device
+ CHG I.V. Securement Dressing
Reference
1877-2100
ID number
70200775479
Lot number
All lots
1879-2100
70200775503
All lots
Remark: 3M™ Tegaderm PICC CVC Securement Device + CHG I.V. Securement Dressing with reference number
1877R-2100 and 1879R-2100 are NOT concerned by this corrective action.
Example for pouch label of 1877-2100
in scope of this FSCA:
Example for pouch label of 1877R-2100
NOT in cope of the FSCA:
Sitz: 41453 Neuss · Handelsregister: B 1878 Amtsgericht Neuss
Geschäftsführer Dr. John Banovetz, Prof. Dr. Joerg Dederichs, Michael Peters, Rob Schokker
Vorsitzender der Geschäftsführung: Dr. John Banovetz; Vorsitzender des Aufsichtsrates: Günter Gressler
3M Deutschland GmbH
Seite 2
Description of the problem:
The concerned products do not bear the correct labelling as required by European legislation and should therefore
no longer be present in the European market. There is no problem with the products inside the pouches. And they
are identical to the European version as sold under 1877R-2100 and 1879R-2100.
Potential hazard and risk for the patient:
The potential hazard is that the devices might not be applied according to the instructions for use because local
language is missing.
Action to be taken by the user:
•
•
•
Read and distribute this information
Isolate and dispose all concerned products.
Fill in the confirmation form and send it back to 3M.
Transmission of this Field Safety Notice:
Please pass on this notice immediately to all departments who might use the concerned products. Moreover,
ensure that the information is provided to any organisation where the concerned products potentially have been
distributed.
Thank you for your immediate attention and cooperation. We apologize for any inconvenience this situation may
cause.
Contact reference person:
If you have questions, please contact the undersigned or your local 3M representative.
The undersigned confirms that this notice has been notified the appropriate Regulatory Agency.
3M Deutschland GmbH
Seite 3
Confirmation Form – FSN 2017-02 FSCA Tegaderm PICC CVC
Please complete and return this form by e-mail or by fax to: 3M Deutschland GmbH, Dr. Marie Isabel Cobbers,
eMail: [email protected], Fax: +49-2131 14124792
Please examine your stock immediately to determine if you have the following lots of the product:
3M™ Tegaderm PICC CVC Securement Device + CHG I.V. Securement Dressing
references 1877-2100 and 1879-2100
If you have any product of the concerned reference numbers, isolate and dispose the concerned products.
Please indicate your response by completing the following information:
We have examined our inventory, isolated and disposed the following amount of the concerned lots of the
product:
Product name
Reference number
3M™ Tegaderm PICC CVC Securement
Device + CHG I.V. Securement Dressing
1877-2100
3M™ Tegaderm PICC CVC Securement
Device + CHG I.V. Securement Dressing
Number of pouches
1879-2100
We have examined our inventory and do not have the above specified 3M products.
We hereby confirm that we received and understood the information about the Field Safety Corrective
Action and that the notice has been passed to all those who need to be aware within our organisation or to
any department or third party organisation where the affected product has been supplied to.
Person completing this form:
(Name)
____________________________________________
(Signature)
____________________________________________
(Date)
____________________________________________
(Customer/Hospital Name)
____________________________________________
(City, State)
____________________________________________
(Phone)
____________________________________________
(email)

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