From the device history record, gown 9545ncc,lot# 2508bq was manufactured on 31st aug to 06th sep 2018.No exception was recorded in the device history record that could lead to the reported incident.No sample was returned for investigation.Supplier reviewed their environment control, temperature/humidity, differential pressure, air exchange time, particle, settling microbe, planktonic bacteria and surface microorganisms monitor/test record from jan to dec 2018, all are within the specification.There is no abnormal situation found.According to the production environment control procedure, each workshop shall do the routine daily clean and comprehensive clean once or twice a week.From the investigation, the root cause could not be determined.There is no action taken at this time, but supplier will continue to monitor the trend of this type of incident.From the device history record, gown 90270nba, lot#0549ba was manufactured on 15th to 16th feb 2019.No exception was recorded in the device history record that could lead to the reported incident.No sample was returned for investigation.Supplier reviewed on the factory working environment control process.Operators clean the ground and counter tops every 2 hours to maintain the cleanliness of the floor/counter tops.They checked the relevant environmental cleaning record and did not find any deviation.The raw materials were all provided by cardinal health, there is no change in raw materials and no deviation found during the production process.From the investigation, the root cause could not be determined.There is no action taken at this time, but supplier will continue to monitor the trend of this type of incident.
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