(b)(4).A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.The sample was returned for evaluation.A visual exam was performed and it was observed that the tube was disconnected and the tubing was damaged.The dimensions of the tube and adapter were measured and were found to be within specification.In the current manufacturing procedure, a 100% visual inspection is conducted after the assembly process; therefore, a defect of this type would be detected prior to release.Based on the investigation performed, it was determined that the detached tubing was most likely caused by mishandling of the product during usage.
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