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 syringe 5ml saline fill china sp had too little solution in the tube.This was discovered during use.The following information was provided by the initial reporter: on (b)(6) 2020, the patient came to our hospital for treatment due to acute gastritis.After the infusion of the patient was completed at 14:40, the nurse found that there was too little solution in the prefilled sealing tube, which was easy to cause the failure of sealing tube and blocked tube.The prefilled sealing liquid was replaced in time and reported to the medical equipment department.
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