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.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.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.Investigation conclusion: this is the 2nd complaint for lot # 9009885 for this type of defect or symptom.Previous complaint (b)(4).There was no documentation for this type of defect during the entire production run of this batch.Root cause description: undetermined.Rationale: capa not required at this time.
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It was reported that prior to use mold was discovered on the top of plunger with a bd 60ml syringe luer-lok¿ tip.The following information was provided by the initial reporter, translated from (b)(6) to english: during one of our processes, we noticed that (before opening the package) a 60 ml syringe unit had dirt on the top of the plunger, appearing to be mold.
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