Date of event: unknown.
The date received by manufacturer has been used for this field.
Two photos showing 5ml syringes in bags (p/n 309649).
In one photo it was observed that a label had been placed on the syringe and the tip had been capped.
Approximately 1ml of an unknown medication was also present in the syringe it was unclear in this photo if any leakage was occurring.
Another photo displayed an identical scenario to the first photo except it appeared that medication had leaked past the back rib of the stopper which is a non-conforming condition per product specification.
A physical sample that clearly displays the defect is required for a more thorough evaluation, leakage testing, and potential root cause determination.
Since root cause could not be defined, corrective actions are not necessary at this time.
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.
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.
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