Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.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.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: based on no sample, the investigation concluded, bd was not able to verify the indicated failure.This is the 1st complaint for lot # 9196132 for this type of defect or symptom.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 the bd posiflush¿ syringe leaked while flushing the indwelling needle for a patient with "mild acute pancreatitis and hypertension".The following information was provided by the initial reporter, translated from (b)(6) to english: "due to mild acute pancreatitis and hypertension, the patient received a doctor's appointment.On (b)(6) 2020, the medical staff used the prefilled syringe to flush the disposable intravenous indwelling needle, and found the liquid extravasation of the irrigator.He stopped using the irrigator immediately, and replaced the new irrigator, and sealed the catheter successfully.".
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