Date of event: unknown.Initial reporter phone# : (b)(6).Initial reporter zip code : (b)(6).Investigation summary : exec summary: no samples (including photos) were returned therefore bd was not able to duplicate or confirm the customer¿s indicated failure and the root cause is undetermined.A review of the manufacturing records was performed and this is the 2nd related complaint for needle hub separates 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/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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