The product was not requested to return for manufactures laboratory investigation because the reported failure is known to mcp and was investigated within a similar complaint (b)(4) with results as follows: the returned product was investigated in the laboratory of the manufacturer.The product was not returned in its original carton outer box.By visual inspection it could be confirmed that the tyvek peel cover was opened at one edge of the unitray.No abnormalities were detected regarding the content of the unitray.Thus the reported failure could be confirmed.A trend review was performed.18 similar complaints were found.Due to this no systemic issue could be determined.Furthermore a dhr review was conducted for the lot in question.There was no rework or scrap record performed during production activities.The product was not used for patient treatment.The event has been reported with a delay due to our retrospective examination of the record.At the time (2019-04-08) the complaint was reviewed and found not to be reportable.Current day, we compared the record with equivalent events, and found an inconsistency with the reporting decisions.With the current knowledge and the current team of complaint handlers, we have come to conclude the event should have been reported.As a remedial effort, we will report it within capa # (b)(4).
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