A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The returned sample was visually inspected and confirmed the black line detached from the probe engine due to lack of solvent.The root cause is consistent with a manufacturing error where the driveline appeared to have lack of solvent.In order to mitigate the occurrence of this type of event, during the manufacturing process, downstream in-process checks after final assembly are utilized to help screen out this type of defect from occurring.After an investigation of this complaint, it has determined that no further actions will be pursued at this time for this event.No adverse trends have been observed associated with the reported product and event.It should be noted quality in-process controls are in place to assist in mitigating a probe aspiration issues.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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