Date of event: unknown.The date received by manufacturer has been used.Investigation summary: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one unit and two photos.During the visual examination it was observed that the needle cover was not present inside of the package, the needle was bent, and the seal was not complete.Your reported defects were confirmed and are likely related to misalignment during packaging.The bent needle and incomplete seal were determined to be a result of the missing needle cover.Preventative maintenance and quality inspections are performed at regular intervals to mitigate the risk from these types of defects.A device history record review showed no non-conformances associated with this issue during the production of this batch.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
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