Investigation summary: one photo was received showing a filled 10ml (p/n 302995) syringe.The photo clearly displayed the syringe scale, which had areas of small and large breaks, along with missing print on every single grad line and the bd logo.It appeared that the markings had been scrapped off.The syringe was non-conforming per product specification.Batch #1082982 is considered in compliance with our product specification requirements.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Investigation conclusion: 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.Root cause description: potential root cause for the missing print defect is associated with the assembly process.It is likely the print was scraped off as part of a jam during the barrel feeding process in the assembly machine.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Rationale: capa not required at this time.
|