A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.A lot will not be released without meeting all criteria.A physical sample was not received for evaluation.However, one photo was provided.The photo was visually analyzed and showed a needle penetrating the lid of a container (it is presumed to have been autoclaved).The containers are suitable for autoclave per the instructions for use and are designed to withstand up to 3.4 lbf of force by a needle in accordance with standards.The label indicates the maximum height the container may be safely filled to.In-process controls are in-place to ensure the label placement is accurate.Overfilling the container during autoclaving can lead to the condition reported.Based on the information available and the investigation findings, a corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.If additional information is received warranting further analysis, the investigation will be resumed.This complaint will be used for tracking and trending purposes.
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