(b)(4).Batch #: p9498r.Device analysis: the analysis results found that the 2b5lt device was returned with the sleeve and the obturator cannula damaged bent and inserted through the sleeve.In addition, the tyvek was returned along with the instrument.No conclusion could be reached as to how this issue occurred.The reported complaint was confirmed.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.The lot history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the packaging process.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
|