(b)(4).Any packaging non-conformance that results in a breach of the sterile package (i.E.Pinhole, tear or seal issue), has the potential to result in a serious infection.In this case, minimal information regarding this event was received.The root cause of this event cannot be conclusively determined with the available information.The subject device was not returned for evaluation.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.If new information becomes available, a supplemental report will be submitted.
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H3: evaluation summary: four out of the five alleged devices were returned.Per evaluation of the four returned devices, customer report of damaged packaging was confirmed.There was no breach to the sterile barriers.Wrinkled labeling was apparent on the brown corrugated packaging box.As received, the shelf boxes of the returned devices were found damaged with multiple creases and dents.No other visible damage, contamination, or other abnormalities were observed from returned devices.Photos attached by complaint handler appeared consistent with lab findings.It should be noted that the alleged sterility breach was noted on the device that was not returned.However, without a device to evaluate, a sterility breach could not be confirmed.H10: additional manufacturer narrative: updated sections d10, h3, h6 h11: corrected data: updated section h10 (additional manufacturer narrative) any packaging non-conformance that results in a breach of the sterile package (i.E.Pinhole, tear or seal issue), has the potential to result in a serious infection.In this case, the damaged noted on the external box is consistent with damage incurred during transfer/shipment.However, a definitive root cause could not be identified.Pika shelf and shipping cartons are visually inspected for damage upon receipt, as well as prior to sterilization.Additionally, any box damage would have likely been noted during assembly and packaging at edwards.Per the instructions for use (ifu), "do not use if device shows signs of damage (i.E., cuts, kinks, crushed areas), or if package is damaged or open." additionally, device packaging states, ¿do not use if package is damaged.¿ the device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
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