One actual device and twelve (12) retention samples were received for evaluation.A batch review was conducted and there were no deviations found related to the reported condition during the manufacture of this lot.A visual inspection of the actual sample was performed with the naked eye and a cut in the tubing was noted.A visual inspection was performed to the primary package finding that it also presents a cut.The position of the cut in the primary package matches with the position of the cut in the patient line.An integrity test was performed to the actual sample, obtaining unsatisfactory results, the leak was detected.The reported condition was verified.The assignable cause of the leak was determined to be a cut in the tubing of the patient line.An assignable cause of the cut could not be determined.A visual inspection of the twelve (12) retention samples was performed and there were no visually detectable perforations or damage.Should additional relevant information become available, a supplemental report will be submitted.
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