Initial reporter phone #: unknown.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.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.Examination of the product involved may provide clarification as to the cause for the reported failure.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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It was reported that leakage occurred during use with a 3 ml bd luer-lok¿ luer-lok¿ tip.The following information was provided by the initial reporter: it was reported that insulin accidently spilled out, customer was not sure if it was due to the syringe being damaged or user error."description of issue: customer reported insulin spilled out by accident.Customer is not sure if the spill was due to damage to the syringe or user error.Number of occurrences: 1.Did the customer insert the needle into the cartridge and encounter fill resistance? no.Proceed to step 4.Item number: 3 ml syringe 309657, 26 g, 3/8" needle 305110, product lot number: 8290715 (syringe), 9829658 (needle), for bd product only, are samples available for investigation? no.Did issue cause any injury? if yes, what type of injury? no.Medical intervention needed? if yes, who was the 3rd party and what was the assistance/treatment? no.
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