Risk of small graft tears during removal of beading material not according to IFU for a range of ePTFE Small Beading Vascular Graft products

Bard Singapore Pte Ltd would like to inform healthcare professionals about the risk of small graft tears during removal of beading material not according to Instructions For Use (IFU) for a range of ePTFE Small Beading Vascular Graft products. Through post-market trending, Bard has identified that in up to 0.25% of the cases, the removal of the beading from the graft during preparation for use can result in small tears in the graft material when the removal technique noted in the IFU is not followed. In the event that the grafts were to tear, the immediate or long-term health consequence that may result involve the potential for bleeding due to sub-optimal anastomosis. Healthcare professionals are advised to follow the removal technique in IFU. After successfully removing the beading from the graft, the graft shall be thoroughly inspected for tears or damage prior to use. 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.