It was reported that the tracheostomy cannula had a pierced cuff.The distributor of this product is (b)(4).The product was not reprocessed, was used according to the manufacturer's instructions and as per the report this event it was not notified to the distributor by email.A measure action was taken after the problem was identified.According to the report, there is no sample to be collected, and there is no label also.The event was classified as type ii-medium risk.It is unknown if the event occurred during patient use and if there was anyone harmed.After the problem was identified and the device was replaced.
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D5: operator of device, e1: reporter name address, phone number and email are unknown.Complaint notification was received from brazil foreign regulatory authority anvisa.Original user and reporter are not known.No information is available.H3 - other: device has not been returned and is not available for investigation.Investigation summary: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.If the product is returned, the manufacturer will reopen this complaint for further investigation.No trend of confirmed complaints in relation with this issue was identified.
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