(b)(4).Batch # p9128m.The analysis results found that a 5dcs device was returned inside its package unopened.Upon visual inspection, it was observed that the tyvek from the packaging was damaged; it was noted to have a hole in the tyvek, the hole was located at the scissors area, the scissors perforated the red protective cap and the tyvek.The sterility was compromised.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.No conclusion could be reached as to what may have caused the reported incident.The lot history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
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