E.1.Initial reporter phone #: (b)(6).H.6.Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306595 and lot number 1075379.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.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 while using the bd pre-filled saline syringe the push rod could not be pushed.The following was received from the initial reporter: when a patient's picc tube is flushed after infusion, after correctly accessing it, the push rod cannot be pushed hard enough to inject the flushing solution, and the flusher is replaced with a new one.
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