Implanted date: device was not implanted.Explanted date: device was not explanted.510(k): k130520.The actual sample was returned for evaluation.Visual inspection revealed that the lock adapter had come off the male connector and was missing.The lock adapter and the competitor's extension tube involved in this complaint were not returned for evaluation.Magnifying inspection of on the male connector, focusing on the section to be fitted to the lock adapter confirmed it had not been deformed.The adhesion of some white substances which appeared to be dried priming solution, was found.The white substances were removed and the outside diameter of the section to be fitted to the lock adapter on the male connector was determined.It was confirmed to meet the specifications.Reproductive testing was performed.A factory-retained sampling system was connected to an extension tube and the lock adapter was exposed to excessive torque force.The lock adapter came off the male connector.A review of the device history record and shipping inspection record of the involved product/lot# combination was conducted with no findings.Ifu states: do not use if the package and/or device is damaged or if caps are not in place.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, it is likely that the lock adapter of the actual device was exposed to excessive torque force and came off the main body, resulting in the reported difficulty in firm connection of the competitor's extension tube to the actual device.However, the exact cause of the reported event cannot be definitively determined based on the available information, and with the absence of the actual lock adapter, and the competitor's extension tube to evaluate.(b)(4).
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The user facility reported that the involved capiox device lock adapter was not working properly, making it difficult to fix a competitor's extension tube firmly to the male connector on the red stopcock side of the actual sample.The customer used the actual sample till the end of the case without changing it out, and the procedure was completed successfully.The patient was not harmed.
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