The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 29-jun-2023.Investigation summary: a complaint of burette bottom popping off was received from the customer.Twenty unused samples were received for investigation.Through visual inspection inside the packaging, no defects or damages were observed.The packages were then opened, and the burettes were lightly pulled to see if the burette would separate easily.Five burettes separated from the lower part of the set.The customer complaint was confirmed.A device history record review for model 10012564 lot number 22039290 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The manufacturing plant was notified of this defect and an investigation was performed.After investigation, the potential root cause for separation between burette and cap could be related to lack of solvent by failure in the crc solvent dispenser.This failure mode was addressed under a quality notification.The corrective action taken was improvement of crc solvent dispensers additionally, a quality alert was generated to reinforce the escalation of failure in solvent dispensers.A work order will be generated to verify the good condition of crc dispensers.
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