This mdr is submitted as a result of efforts associated with (b)(4) following the complaint handling process during the divesture of the tidi fenton, michigan facility.This capa was created to remediate and transfer complaint information previously handled by the tidi fenton facility.This is the 1st of two similar complaints reported for this product during 2017, neither of these events resulted in a patient, or caregiver injury.During 2017 products associated with this malfunction were returned for evaluation, an inventory inspection and complaint recreation were performed.This product contains two adaptor sizes; a 6.5 mm which is already inserted inside the hose and an additional 8 mm adaptor provided with the product.This complaint event is associated with the 8 mm adaptor.The product malfunction in this event was unable to be recreated at the fenton facility.Although the complaint was unable to be recreated, a process evaluation was performed and critical to quality component areas were identified, and adjusted to improve process consistency.Since these two events in 2017, there have been no similar product malfunctions reported to date for this product number.The original complaint number associated with this event was (b)(4) , the remediated complaint number is (b)(4).
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