Initial reporter:(b)(6).Investigation summary: after the evaluation of the received photos and the photo characteristic, this failure happened due to an incorrect setup, where the operator did not empty the feeder to make the paper change in the sealing station of the machine.The retention samples were evaluated and no failure was observed.Batch history analysis was performed, quality notifications and maintenance records were checked where no records potentially related to failure were found.The operators of the production line will be notified about the occurrence.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: batch history analysis was performed, quality notifications and maintenance records were checked where no records potentially related to failure were found.The retention samples were evaluated and no failure was observed.After the evaluation of the received photos and the photo characteristic, this failure happened due to an incorrect setup, where the operator did not empty the feeder to make the paper change in the sealing station of the machine.The operators of the production line will be notified about the occurrence.Notification will be registered in the note: (b)(4).Additionally the incident identified from this complaint will be monitored for trend assessment.
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It was reported that 8 bd plastipak¿ 10ml syringe slip tips experienced damaged or open unit packaging/seals where sterility was compromised.The following information was provided by the initial reporter: product double labeled, but the package hasn't been sealed, letting the syringes open.
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