Investigation summary: three photos were provided.They show a shelf box with the side flap partially out.Another photo shows a person pulling the side flap out.The shelf box is not fully closed.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.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.Investigation conclusion: confirmed: bd was able to duplicate or confirm the customer's indicated failure mode with the photos provided.This is the 1st complaint for lot # 8141906 for this type of defect or symptom.There was no documentation for this type of defect during the entire production run of this batch.Root cause description: this could have been caused during the shelf box packaging process.Rationale: based on the investigation, no additional investigation and no capa is required at this time.
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It was reported that the bd posiflush¿ syringe packaging wasn't tightly sealed and the product fell out easily.The following information was provided by the initial reporter, translated from (b)(6) to english: "the packaging is not tightly sealed, the products are easy to fall out when taking".
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