(4109/213) as the occurrence of this type of event is low, it was decided to perform an additional review of historical data over the last five years (from january 2017 to may 2022) which indicated that another similar complaint was reported.Regarding this complaint, the conducted investigation indicated that the device was not defective at the time of manufacturing.It was noted that it was highly unlikely that an omission had occurred during the packaging stage because each component is scanned individually.(4110/213) occurrence rate was calculated for similar events on the same manufacturing line (intergard/hemagard) for a 5 years period from 1- jan-2017 to 31-may-2022.The occurrence rate was inferior to (b)(4)%, which is below the anticipated occurrence rate (maximum) of (b)(4)%.(10/4248) a visual inspection of the returned product was performed by the quality assurance (qa) supervisors: "the box is very damaged.Only the leaflet accompanies the box.None of the following elements were present: outer shell, inner shell, product and patient set.Note that the 2 tamper-evident labels are positioned on the sides of the box.".They concluded that, considering its condition, it seems very likely that the product was lost when the box was opened.(19) no conclusion can be drawn on the exact origin of the defect since the product was manipulated by the user.However, based on the qa supervisors assessment, it seems very likely that the the cause of the event is related to the user.
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