(b)(4).The review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.Actual sample was received for evaluation.During the visual inspection of the suture pieces, it was observed body fluids along of the strands and the ends were cut.Also, the barbs were present on the suture pieces; however, the barbs could not be measured since the samples are an absorbable suture and was returned opened, the degradation process already has begun resulting in a damaged suture.According to the sample condition, it could not be determined what may have caused the reported incident.
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