A visual inspection of the catheter revealed a hole distal to the hub to lumen junction.The hole is "v" shaped.A review of the manufacturing records indicated that all device specifications and quality requirements were satisfied.This device family is 100% leak tested at the end of the manufacturing process which would detect any failures.We are unable to determine the exact cause of the failure however it appears that the device came into contact with a sharp edge, such as a needle bevel, at some point.There is no evidence of a manufacturing defect.
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