Investigation summary: it was reported the plunger could not push the plunger past the 7ml graduation mark.To aid in the investigation, two samples with no packaging flow wraps were received for evaluation by our quality team.A visual inspection was performed.Each sample has 4ml of solution and no defects or imperfections were observed.Each sample was then tested for sustaining force, which is the force applied to the plunger rod while moving downwards when expelling the saline solution, and all results were within specification.A device history record review was completed for provided material number 306546, lot number 2151804.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed and a probable root cause could not be offered.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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