Investigation summary: photos or samples are not available for analysis.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of irritation/ inflammation with lot #7360956 regarding item #388335.A review of the device history record was completed for sub-assembly #004713bjf, lot 7331984 manufactured from 30-nov-17 to 30-dec-17 at acam #3 used in lot 7360956 claimed.This lot was reviewed regarding the tests of needle tip penetration, catheter tip penetration and drag catheter test, and it was not evidenced results of these tests out of specification and no other records were found that could lead to this complaint.No records of quality notification or reports of non-conformity that could lead to incidents in to the lots involved in this complaint were evidenced.Investigation conclusion: without samples for analysis, it is not possible to confirm the defect of irritation/ inflammation reported in this complaint.It was not possible to verify this complaint as being generated by manufacturing process.Root cause description: based on the investigation results to date the root cause was not determinate for the defect described in this complaint.Rationale: complaints received for this device and the reported defect will continue to be tracked and trended.The information will be captured in the trend reports and monitored monthly.Collected data are regularly reviewed to identify emerging trends.Based on this, a capa is not needed at this time.
|