Initial reporter phone #: unknown.Investigation summary: no samples were received.No photos were provided.However, it may have happened a jam at the plunger rod- stopper assembly process and not detected in the next process.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.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.This is the 2nd complaint for lot # 9260238 for this type of defect or symptom.Root cause description: it may have happened a jam at the plunger rod- stopper assembly process and not detected in the next process.Rationale: capa not required at this time.
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It was reported that during use the barrel was discovered to be cracked during use with a bd syringe 5ml saline fill sp.The following information was provided by the initial reporter, translated from chinese to english: during using, it was found that the barrel of the pre-flush syringe with normal outer packing was broken and it couldn't be used normally.Replaced with the qualified product for operation.
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