Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: based on no sample, the investigation concluded, bd was not able to verify the indicated failure.This is the 1st complaint for lot # 9206061 for this type of defect or symptom.Root cause description: no root cause can¿t be determined as no samples were received.Rationale: capa not required at this time.
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It was reported that the bd¿ pre-filled normal saline syringe was used to flush the catheter needle before use, but one end of the barrel was found damaged.The following information was provided by the initial reporter, translated from "at 18:18 on (b)(6) 2020, according to the doctor's advice, the nurse gave infusion to the child.Before infusion, the indwelling needle was pre-flushed.It was found that one end of the flush was damaged, so it was replaced with the new flush, there was no any bad consequences.".
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