Summary of investigation: actual device was available for investigation.The sample was visually inspected at a distance of 12" to 24" under normal conditions of illumination.The sample was received with the catheter attach to the port, and a crack was found in the catheter.After a review of the different verifications that are performed during the manufacturing process to detect damage components, the most probable root cause is that damaged occurred after the product left the shm facility.A dhr was conducted which indicated all inspections were completed and no issues were noted during manufacture.
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