Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).Results: no samples were received from the customer in support of this complaint, but a photo was attached showing a tube whose cap had a vertical split in it.Visual examination of the 200 retained samples from the implicated lot number did not identify any instances of damaged caps.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6284671.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.
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