Pr (b)(4) follow up mdr for device evaluation: one photo which displays the product packaging was provided, however, no photos or physical samples that display the reported condition were provided to our quality team for investigation.A device history review was performed for lot 2302024, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Five retained samples of the same lot were used for additional evaluation.The product was visually inspected, no damage or defects were observed on or near the luer connection.Functional testing was performed, in all cases the product met required specification and no leakage was observed.Product is visually and functionally tested throughout manufacturing according to procedure, verifying all critical dimensions are within specification.Testing results for lot 2302024 verified product met all required limits.Based on the available information we are not able to identify a root cause at this time.Complaints received for this device and reported condition will continue to be monitored by our quality team for signs of emerging trends.H3 other text : see manufacturer narrative.
|