Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.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.Investigation conclusion: since no samples displaying the reported condition were received a potential root cause could not be defined.Since no samples displaying the reported condition were received corrective actions are not necessary.
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It was reported that the bd 60ml syringe luer-lok¿ tip experienced a needle hub hole/crack/damaged.The following information was provided by the initial reporter: material no: 309657 batch no: unknown (reported 200101).Caller reported hole in the side of the syringe.Number of occurrences - 1.Did the caller insert the needle into the cartridge and encounter fill resistance? - no did issue cause any injury? - yes, insulin squirted into eye from the hole caused a little bit of irritation.Medical attention was not necessary, customer waited it out and issue resolved.Did customer require medical intervention? - no.
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