Date of event: unknown.The date received by manufacturer has been used for this field.Investigation: two representative samples were received for evaluation.Visually the samples not present any damage, only the tray has damages.Both samples will be tested functionally by device activation.Dhr for lot number 6302611 was reviewed and no qns or other events were related to the complaint stated by the customer.Material (b)(4) with lot number 6302611 was manufactured on november 25, 2016.According to sampling plan applied for product performance, this lot was accepted and released.During this lot number 140 samples were activated by qa tech to perform 3 test of pull force.Stylet/cannula removal force through inserter wings.Stylet/cannula removal force through the prn component.Outer safety sheath disconnection force from prn component.No values out of specification or problems during activation were found.All relevant information during the dhr review shown that meet all established manufacturing criteria.No internal rejection was generated during the manufactured of this lot number.We could not determine a root cause for this issue, it is possible that the failure occurred during incorrect use of the device.Dhr did not showed evidence of an issue related to the reported by customer.Bd was not able to duplicate or confirm the customer¿s indicated failure mode investigation comments: after evaluate two representative samples we were not able to associate the reported defect to the mfg.Process.This reported defect could be related with an incorrect use of the device by user and a possible cause to leave exposed cannula, it is that during the device activation is made since adapter sti prn, removing safety mechanism.Instruction sheet (b)(4), show correct way to perform this activation.Representative samples were functionally tested and meets specification criteria requested during manufacturing.Based on investigation results to date, root cause for manufacturing process cannot be determined.(b)(4).
|