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 blue aspiration fitting was deformed.The deformed connector resulted in customer experience.After an analysis.And based on the condition of the sample, the root cause is potentially related to an error, during the suppliers manufacturing process of the aspiration connector.After an investigation of this complaint.It has determined, that no further actions will be pursued at this time.The supplier has been made aware of the issue.No adverse trends have been observed, associated with the reported product and event.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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