Investigation summary: in response to the event reported by the facility a device history review was conducted for lot number 1050046.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Bd will continue to monitor this issue.Investigation conclusion: the complaint gauge is 24g,assembly at auto line 2 in mar.2021,packaging at r240 packing machine in mar.2021, lot quantity is 186k.Review of the in process test and outgoing test report for this lot product were performed, all test results meet the product specifications, no abnormality found for it.Review of the production record and machine troubleshooting records for this lot product were performed, no abnormality, deviation or rework activities found.No actual sample or picture returned, due to the unclear description, the specific leakage point cannot be confirmed.Leakage test the 2 retained samples, all passed.No same complaint was received from the complaint lot.No abnormality found on process, as no defective sample returned, further analysis could not be done, the root cause of indwelling needle leakage could not be determined.
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