Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
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It was reported that syringe 1ml 29g 12.7mm 10bag 500 eu leaked.The following information was provided by the initial reporter: the patient contacted regarding insulin syringes.He injects painkillers with syringes.When he inject, some of the liquid will drain past the syringe.In addition, the injection sometimes makes you sore and the injection site also becomes bloody.
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