Qn# (b)(4).Ten representative samples were returned by the customer and sent to the manufacturing site for investigation.The manufacturing site reports: 10 pieces of representative sample were received.The samples were closely examined by visual inspection and no issues were found.It was also reported "from the description, it seems that the secretions found on the filter may caused by the accumulation of secretion from patient after usage.Ifu stated that replace device 24 hours or as needed to prevent accumulation of secretion.Replace unit immediately if soiled with secretion or otherwise obstructed.Besides that, trach vent should not be used with patients producing fulminating frothy secretions within their airways, or patients with haemoptysis.In current manufacturing procedure, visual inspection during assembly process at assembly area is conducted.Thus, any ineffective products will be culled out during this process.Furthermore, there is no material and process change since the product validated." a device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint could not be confirmed.The actual device was not returned and there were no issues found with the returned representative samples.
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