According to the sales and service unit the primarily packaging was damaged.Based on this the failure could be confirmed.Most probable cause: in regards to the issue concerning the punctures from inside to outside an inappropriate handling (upside down) can be concluded.If the welding points of the inlay become loose, it will allow the product within the inlay to move.As a consequence, the holder of the venous probe may cause damages in terms of two punctures through the tyvek cover.Furthermore a dhr review was conducted for the lot in question.There was no rework or scrap record performed during production activities.A trend review was performed.20 similar complaints were found.Due to this no systemic issue could be determined.The failure was detected during incoming inspection.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 (2018-04-06) 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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