(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A visual inspection of the product involved in the complaint was performed on two pictures provided by the customer of two components that are part of product code 1883 (micro mist nebulizer w/tee, tbg & mthpc).Customer complaint is not related to a visual issue it is related to a dimensional defect, no visual issues can be observed that can lead to this customer complaint.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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