Date of birth: patient¿s age in years at the time of the event was not provided, 71 was calculated based on date of birth of patient of (b)(6).Investigation summary : exec summary - no samples (including photos) were returned therefore bd was not able to fully investigate this incident, either to duplicate or confirm the customer¿s indicated failure and the root cause is undetermined.A review of the complaint lot history check was performed and this is the 1st related complaint for leakage at syringe on this lot #.No non-conformances were raised in association with this type of event for this lot concluding all inspections were performed as per the applicable operations and met qc specifications.Capa/sa - based on the above no additional investigation and no corrective or preventative action (capa) or situational analysis (sa) are required at this time.Dhr review - a lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.
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