No device was returned for evaluation.The contract manufacturer conducted a review of the manufacture records for the lot number provided.Their investigation revealed the devices were manufactured and inspected according to specification with no non-conformances or abnormalities.The manufacture process includes a 100% leak test performed as a last step in the process.This test would have detected any holes, leaks, or inferior connection to the hub if the issue existed at the time of manufacture.Without an evaluation of the complained device a root cause cannot be determined.The instructions for use (ifu) were reviewed and include sufficient information, warnings, and precautions regarding the use and care of the device.A review of complaint history for these devices revealed these are the only complaints of this type for this device family.Based on historic data this is not a systemic issue and is considered isolated.This type of event will be trended through the complaint handling process.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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