(b)(6).Mdr 3007966929-2019-00063 / device 6 of 6.Based on the available information, this event is deemed to be a reportable malfunction.A batch record review was performed.No non-conformance report related to complaint issue were initiated for complaint order during production.Manufacturing data for the affected handyvac products were reviewed for the period from may 01, 2016 to may 01, 2019.The complaints were reviewed for the period from (b)(6) 2016 to (b)(6) 2019, on the presence of the similar issue ¿drain will not keep vacuum¿.A total of two (2) complaints on seven defective items were received.Based on the medical review of the complaint, the product malfunction code was identified as disconnection of the drain from the drainage collection device; or connection is loose, leakage may occur.No harm was reported with the complaints.The calculated probability of the failure occurrence for 2016-2018 was performed, the risk has been evaluated as ¿low¿.No samples were received.Pictures were received.Pictures did not lead to any conclusions.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).
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