Qn#: (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 a video received by the customer of product code 1885 (micro mist nebulizer w/elong).During the visual inspection on the received video, the tubing disconnection from nebulizer was observed.Although, tubing disconnected from nebulizer was observed on the provided video, the sample needs to be evaluated to confirm this issue as a manufacturing defect.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 "the nurse was preparing to atomize the patient, and when the product was assembled, it was found that the connecting port of the product connecting tube and the bottom of the medicine cup slipped naturally during installation, and it could not be connected and used normally".No patient involvement reported.
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