Qn#(b)(4).The customer returned one, unopened psi kit for analysis.The seal between the lid stock and the tray was completely intact and secure.Visual analysis of the returned kit revealed that the bottom right corner of the tray contained a crack.Stress marks were also identified around the edges of the crack.A device history record review was performed, and no relevant findings were identified.The report of a sterility issue was confirmed through complaint investigation.Visual analysis revealed that the bottom-right corner of the tray was cracked.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, design caused or contributed to this event.A non-conformance request was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.
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