Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: although the sample was not returned for evaluation, two electronic photos were provided for review.The investigation is confirmed for deformation in rigid packaging components, as warping/bending was identified in two rigid packaging components.The curvature of the deformation appeared to be the same in both components.Although a definitive root cause could not be determined, excessive heat during shipping/storage could have potentially caused or contributed to the reported event.It is unknown whether patient and/or procedural factors contributed to the event.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.(expiry date: 01/2021).
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