A review of the returned drain confirmed the presence of a large crack in the lower front panels of the drain.A crack of the drain of this nature could only be caused by a very blunt force applied such as a drop of the drain or shipping and handling damage.The drains during the process of manufacturing undergo a full system pressure test to ensure the integrity of the drain.A crack of this nature would have easily been detected and rejected by the automated system.This crack is also large enough that the manufacturing operator would have been able to visually see the crack as well.A review of the device history records indicates that the lot of chest drains passed all quality and performance requirements prior to being released.The instruction for use state "do not use if device or package is damaged".Summary/conclusion - based on the results of the investigation the most probable root cause of the cracked oasis chest drains is that the product was damaged while in transit.A large crack would have been noticed during the multiple manufacturing process steps in manufacturing including the 100% product leak test.
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