Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Investigation conclusion: 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.Root cause description: no root cause can be determined as no samples were received.Rationale: capa not required at this time.
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It was reported that 10 ml bd posiflush¿ normal saline syringe plunger could not be moved.This was discovered during use.The following information was provided by the initial reporter: on (b)(6) 2020, the patient was hospitalized for hemopenia.During the treatment, the plunger of pre-filled syringe could not be moved, so it was immediately stopped and replaced.
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