Based on the available information, this event is deemed to be a reportable malfunction.Based on the available information, no patient harm occurred.No additional patient/ event details have been provided to date.Should additional information become available, a follow-up report will be submitted.Note: nine (09) cases are associated with this complaint.Separate 3500a forms have been completed to for the other cases.(b)(4).
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A batch record review was performed on the finished lot and all sub-assemblies associated with lot # 5e01364.The batch record review indicated a discrepancy with one mix lots used to produce the product.The discrepancy had no impact on this reported event, as the suspect material was identified, quarantined and destroyed.There were no other discrepancies.The sterilization certificate was reviewed and concluded that the associated lot was sterilized according to procedure.Process checks were performed.No further action is required and this complaint will be closed.This issue will be monitored through the post market product monitoring review process.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).
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