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Health Sciences Authority
Dear Healthcare Professional Letters

Field correction for BARD® Single Lumen Groshong NXT ClearVue Catheter due to defective connector

Audiences

Healthcare professional

Industry member

Product type

Medical devices

18 May 2021

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

A Dear Healthcare Professional Letter has been issued by Bard Singapore Pte Ltd to inform healthcare professionals of a voluntary medical device field correction of the BARD® Single Lumen Groshong NXT ClearVue Catheter due to two issues identified with the connector of the product, with a complaint rate of 0.178%. The inner diameter of the distal connector may be reduced resulting in the inability to pass the catheter through the connector and the catch slot on the distal connector may be deformed resulting in the inability for the distal connector to properly lock onto the associated proximal connector section. The use of a defective connector may result in the potential for leaks, catheter embolization and infection requiring medical intervention. Healthcare professionals are recommended to follow the instructions for use to confirm that the components are properly engaged before continuing with the procedure. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.

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