The product was investigated in the laboratory of the manufacturer with the following outcome: before opening the tub, the tensile test (checking the seal seam strength on the transport packaging) was carried out on the welded-on tyvek cover.The result was ok.During visual inspection several damages at the outer carton box were detected.Beside of this the tyvek peel cover was forced through.It was also determined that the quadrox's inlay within the tray, which is connected to the trays inner wall by welding spots, was unsoldered.Due to this the blood outlet connector of the unsecured product within the tray was able to force through the tyvek peel cover.This was most probable caused due to excessive physical force during transport.Thus the reported failure could be confirmed.A trend review was performed.21 similar complaints were found.Due to this no systemic issue could be determined.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 (b)(6) 2018, 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).
|