Investigation summary: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received two photographs and one sample of a 18gx1.25in nexiva unit from lot number 2325434.The photographs display similarities to that of the returned unit.Two nexiva devices were contained in the unit packaging and one device was caught in the seal, which created a breach in the sterile barrier.A portion of the device that was caught in the seal had been cut away when the packaging was trimmed and rendered the device unusable.The reported issue was confirmed.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to the packaging process.A device history record review showed no non-conformances associated with this issue during the production of this batch.
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