Qn#: (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor, and trend for reports of this nature.If the sample becomes available at a later date, a follow up report will be submitted with investigation results.
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It was reported that, "nebuliser failed to aerosolise, just product bubbles.Obtained another, worked as intended." alleged issue detected prior to patient use.No patient involvement reported.
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