(b)(4).A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.The device was manufactured according to release specification.The device was returned for evaluation.A visual exam was performed and it was observed that the sample was assembled correctly.A drop test could not be conducted as the sample was received wet.The instructions for use (ifu) mentions that filters should not be used with patients producing fulminating frothy secretions within their airways, or patients with hemoptysis.The filter is to be replaced immediately if there is increasing resistance or any suspicion of contamination, occlusion, or other indications of malfunction present.In addition, to prevent accumulation of condensation, position the filter to allow water to drain away from the upstream side of the filter.Based on the investigation performed, the reported complaint could not be confirmed.The customer complained that the product was blocked; however, based on the visual inspection, the product was assembled correctly.Drop testing could not be conducted as the returned sample was wet.In the current manufacturing procedure, a drop test and other remarks: visual inspection after assembly of the product is conducted; therefore, any ineffective products would be detected during this process.
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