The event is deemed to be a reportable malfunction as it is uncertain whether the integrity of the sterile package may have been compromised.The investigation of the returned product and packaging verified that leakage occurred based on lower volume of liquid and smeared labeling.A root cause was not able to be identified for the complaint allegation of leaking tube as the returned product was received open with the tamper-evident seal and tube shrink wrap removed.When pressure was applied to the inverted tube no leaks occurred.There is no noticeable damage to the product tube, cap, or packaging.The device history record for batch 15h214 was re-reviewed and no related nonconformances were identified; the torque machine and capper were within specifications at the time of use and visual inspections and final visual inspections by 2 independent reviewers met the requirements at the time of release.To date, no additional complaints were reported from this product batch.No complaint trends were identified for the issue of leaking tube.The complaint issue will continue to be monitored within artegraft, inc.Quality systems, quality assurance trending.
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