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MINISEND-LUER LOCK CAP
Notice type:
Advisory
Date:
11/02/2014
Product name or type:
MINISEND-LUER LOCK CAP
Reference:
SN201401
Manufacturer Or Supplier:
Sendal S.L.
Target Audience:
Hospital Managers / CEOs
Risk Managers
Clinical Directors
Nursing Managers
Nursing staff
Purchasing Managers
Supplies Managers
Nursing Managers
Hospital personnel
Private Medical Practitioners
Hospital Pharmacists
All wards
Problem Or Issue:
A potential fault has been identified with the sealing of the primary packaging (blister) of the Minisend luer lock cap, leading to a possible loss of sterility of the product. Not all units are affected, only those with a small sealing surface.
The manufacturer has confirmed that devices on the Irish market, with product reference codes TP-MF and TP-MF-A are affected by this action. Refer to attached Field Safety Notice (FSN).
Background Information Or Related Documents:
The cap is a device used to close the IV lines, normally by screwing them over the Luer lock of the stopcocks, manifolds or other devices for IV infusion.
The manufacturer has determined that a number of hospitals / facilities have received products affected by this fault and that these products were manufactured between January 2010 and January 2014.
MINISEND-LUER LOCK CAP Document
Actions To Be Taken:
Sendal S.L. requires that users check their inventory and quarantine all affected products/lots. In the absence of an alternative, it is recommended that users verify the integrity of the packaging and do not use units where the sealing appears defective.
Sendal requires that users return completed verification forms for this action to the Sendal representative.
The IMB recommends that users forward this safety notice to all those who need to be aware of this action within your organisation and to maintain awareness over this safety notice for an appropriate time period.
Further Information:
ENQUIRIES
All adverse incidents relating to a medical device should be reported to:
Health Products Regulatory Authority
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Telephone: +353-1-6764971
Fax: +353-1-6344033
E-mail:
devicesafety@hpra.ie
Website:
www.hpra.ie
Please quote IMB reference number V19954 for any queries in relation to this action.
Enquiries to the manufacturer should be addressed to:
José Antonio RAMÓN MEDINA
Ctra. Nacional Madrid Cáceres S/N
10350
ALMARAZ
Spain
Telephone: (0034) 93 775 31 51
Fax: (0034) 93 775 33 11
E-mail:
vigilance@sendal.es
Enquiries to the distributor should be addressed to:
Sean McGlynn
Managing Director
MG Healthcare Ltd.
Block 3, Unit 38 Port Tunnel Business Park
Clonshaugh
Dublin 17
Telephone: 01 867 3007
Fax: 01 867 3009
E-mail:
sean@mghealthcare.com
Please click here to view a PDF version of this Safety Notice
Please click here to view a copy of the FSN
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Date Printed: 27/04/2024