(b)(4).Batch # p58c9l.Photographic evaluation: one photo was provided.The picture shows the distal part of the device, the device appears to be in its sterile package a reload is visible and not loaded on the device.Based on the photo alone the event describe is confirmed.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Device evaluation: the analysis results found that the device was returned inside its package unopened.Upon visual inspection, the cartridge was observed to be loose inside the package.No conclusion could be reached as to what may have caused the reported incident.The reported complaint was confirmed.Lot p4t55f: the lot history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the packaging process.Batch p58c9l: the batch 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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