Evaluation of the device revealed a small puncture that can only be seen when stretching the tubing.A review of the manufacture records showed the device was manufactured according to specification with no non-conformances or abnormalities.The manufacture process included a leak test of 100% of these devices.This test would have identified the puncture if it had occurred during the manufacture process.Based on the evaluation of the device, the review of the manufacture records, and the fact that the device was implanted for two days prior to detection of the puncture, it was determined that the root cause is most likely not manufacture related.The instructions for use (ifu) contain the following catheter precaution: do not use sharp instruments near the extension lines or tubing.Do not use scissors to remove dressing, as this could possibly cut or damage catheter.Do not suture through any part of the catheter.Catheter tubing can tear when subjected to excessive force or rough edges.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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