The 510(k) number in the initial report submitted was a typo and is not applicable to this mdr.Following the reported event, product retains from the reported lot were evaluated.No issues were noted; the reported issue was not able to be confirmed.Return product was received from the user facility on july 7, 2021 and following evaluation, the reported issue was able to be confirmed.The return product evaluation reported an absence of methyl ethyl ketone (mek) which is used to weld the cap and tube of the saliva ejector together.The likely root cause of this issue is that during the initial start-up of the equipment, the operators did not scrap the first bag of saliva ejectors produced as stated in the work instruction.The reported event remains an isolated occurrence to this lot.No additional issues have been reported.
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