A hemodialysis clinic manager (cm) reported the clamp failed on the product during patient treatment.According to the cm, a nurse was preparing to attach a syringe containing medication to the line.The clamp appeared to be closed, but blood leaked out after she took the cap off the line.Ebl was approximately 50ml and no medical intervention was required.The patient continues on hemodialysis.The actual sample was returned for evaluation.
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The actual device was returned to the manufacturer for physical evaluation and the complaint is not confirmed.One functional inspection was performed to confirm the alleged product problem.During the inspection, it was found that the clamp was working properly.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material and process controls were within specification.
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