A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual inspection found cracking on luer lock adapter.No other analysis was performed.The root cause of the reported issue was found to be supplier item fault.Notification of the complaint was submitted to supplier on jan/22/2021 to be aware of the issue.An internal scar submitted to supplier for luer connector on 27-nov-2020, in which supplier was notified about the issue reported for broken component.Lot number reported showed that pieces were built with p/n 00-208 with lot number raw material 0004081226 with manufacturing date on april 2019, so based on manufacturing date, this action can be assigned to this complaint.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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