A review of the complaint device history records, indicated that the graft was processed and inspected according to established procedures and was therefore released following acceptable quality inspections and tests.These tests include a 100 % visual inspection of the graft.Specifically, the review of the collagen coating records evidenced no anomaly.The investigation is still ongoing.A follow up report will be sent upon completion of the investigation.
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(10/3221) a visual inspection of the complaint device was performed by our quality assurance (qa) supervisor.The graft arrived in a very poor condition, completely turned inside out and flattened.Therefore, it was not possible to conclude whether the observed absence of collagen was native or generated by the manipulation of the product.(11/213) a second retention sample from same lot and coated on same period and under same conditions as the involved device was visually inspected by our qa supervisor.No collagen peel-off was found.This second retention sample also underwent water permeability testing.The test result indicated a value well within product specifications (< 5 ml/cm²/min).(4109/213) the review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number.(4315) no conclusion can be drawn.The conducted investigation would tend to indicate that the product was meeting its specification at the time of manufacture.However, the product, as it was received, does not conform to the specification.Therefore, a non-conformity report has been initiated in order to investigate the root cause and take appropriate corrective actions if necessary.Please note that, as per instruction for use, care should be taken when handling the graft to avoid damaging the collagen coating.
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