The contract manufacturer evaluated the returned device and reviewed the manufacture records.The review of the manufacture records shows the device was manufactured according to specification.The device was also 100% leak tested after manufacture.Samples were used to attempt to reproduce the issue.The only test of the samples that produced a similar slit in the lumen was the use of a scalpel.Based on the evaluation of the returned device and the review of the manufacture records it was determined that the root cause of this issue cannot be determined but is deemed not manufacturing related.The instructions for use (ifu) included the following catheter precautions: "do not use sharp instruments near the extension tubing or catheter lumen." and "do not use scissors to remove dressing.".Device was used for treatment, not diagnosis.If information is obtained that was not avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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