(b)(4).Investigation summary: a device history record review was performed for provided lot number (b)(4).The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this incident, three physical samples and 2 picture samples were received for evaluation by our quality team.Of the 3 samples that were received, two samples have the plunger rod -rubber stopper all the way down.A visual inspection was performed finding no defects or imperfections.The third sample has 5ml of blood, the plunger rod has a separation of 1/16" to the rubber stopper.The 4 photos were provided show the sample received with blood; in one of the photos the plunger rod has been disconnected from the rubber stopper.Investigation conclusion: based on the investigation and with the sample analysis the symptom reported by the customer could not be confirmed.Root cause description: the cause for this defect could have resulted from off label use, as the product is designed to push the plunger rod down while expelling the solution, versus being pulled back to collect blood.Rationale: we will continue monitoring the complaint trend for this product and symptom.
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