Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd was unable to perform a thorough investigation as no sample, material number, lot, or batch number were provided.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 bd q-syte luer access split septum detached from the stopcock.The following information was provided by the initial reporter, translated from (b)(6): "when terumo's syringe 20 ml was connected to the stopcock, the connection was loose and the syringe rotated.When pulled, the syringe was detached from the stopcock.
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