Updated: BD issue a field safety notice for BD Plastipak 50ml Luer Lok Syringes


#IVTEAM #Intravenous products: Please disregard the previous notification. MHRA have published a medical device safety advisory notice and product recall “BBD has received complaints concerning an increase in the occurrence of occlusion alarms with the BD PlastipakTM 50mL Luer Lok Syringes. The root cause has been determined to be increased plunger rod forces primarily due to the interaction between the syringe barrel and the rubber stopper. Initially BD recommended a change in the settings of the syringe pumps (Field Safety Notification April 8, 2013, MSS-13-191-FA). However, investigation after continued complaints were received has revealed that it was not technically feasible to change the pump settings on some types of syringe pumps. To BD’s knowledge none of the pump companies made adjustments to software, thus clinicians were still experiencing increased occlusion alarming. At the present time, to our knowledge, no patients have been harmed due to the need to change the syringe and the possible short delay in medication delivery. However, BD decided to carefully review and modify the manufacturing process with a goal to reduce the plunger rod forces back to what is expected by the existing syringe pump programmes. BD has been able to reduce the plunger forces on the BD PlastipakTM 50mL Luer Lok Syringe back to a level that should reduce or eliminate the triggering of occlusion alarms when used in syringe pumps. This Field Safety Notification only applies to the BD PlastipakTM 50mL Luer Lok Syringe when used in combination with syringe pumps. There is no clinical concern when the syringe is used manually for all applications.”

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