Date of event is unknown.The date received by manufacturer has been used for this field.While the event date is unknown, it¿s suggested that it happened between april 10 and april 15 of 2022.Investigation summary: it was reported the syringe plunger would not fully advance.As a sample was not returned, a thorough sample investigation could not be completed.It could be possible that the customer is getting some products that are towards the high specification limit and are related to the symptom reported by the customer since they require extra force than normal to expel the solution.A device history record review was completed for provided material number 306546, lot number 2021612.Previous investigations have revealed that improper silicone application within the syringe barrel can create plunger resistance.Several quality initiatives have been implemented on our manufacturing line to ensure that the silicone application is properly applied during the manufacturing process.Additionally, a monitoring program is also in place to verify the silicone is uniformly applied to the syringe barrel.Based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
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It was reported that the plunger did not fully advance while using 10 ml bd posiflush¿ normal saline syringe.This occurred twice, however, no patient impact reported.The following information was provided by the initial reporter: technologist in nuclear medicine have reported on two occasions this week that saline flushes with lot# 2021612 have exhibited the same failure to fully advance syringe plunger.
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