Investigation summary: one used unit was received for evaluation.This sample received with activated safety device completely.Dhr for lot number 6180745 was reviewed and no qns or other events were related to the complaint stated by the customer.Material 383346 with lot number 6180745 was manufactured on july 14, 2016.According to sampling plan applied for product performance, this lot was accepted and released.No values out of specification or problems during activation or exposed cannula were found.All relevant information during the dhr review shown that meet all established manufacturing criteria.Investigation conclusion: after evaluate the sample received and find activated safety device completely, we cannot confirm either to associate the reported defect to the mfg.Process.Conclusion: based on evaluation this reported defect could be related with an incorrect use of the device by user.This is a way to leave exposed cannula after of finishing the puncture, the user performed the device activation since adapter sti prn, removing all the safety mechanism.Root cause description: based on investigation results to date, root cause for manufacturing process cannot be determined, however a possible cause could be the use incorrect of the device by user.
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