Expiration date: 12/2020.Manufacture date: 01/2016.Based on the available information, this event is deemed a reportable malfunction, no patient harm was reported.A batch record review indicated that there were no discrepancies related to complaint issue.Although it did result in a previous discrepancy which was investigated and is now closed.On the base of information received, the investigation concluded that the true root cause for the issue "loss of physical integrity of unometer safeti plus product" cannot be identified.No corrective actions are required at the moment.No additional investigation is needed, this issue will be monitored through the post market product monitoring review process.If additional information becomes available, a follow-up report will be submitted.(b)(4).
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