Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.It could have happened that a jam occurred at the plunger rod assembly process inducing damages to the barrel.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: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.This is the 1st complaint for lot # 9112675 for this type of defect or symptom.There was no documentation for this type of defect during the entire production run of this batch.Root cause description: posiflush assembly line.Plunger rod assembly.It could have happened that a jam occurred at the plunger rod assembly process inducing damages to the barrel.Rationale: capa not required at this time.
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It was reported that the bd posiflush¿ syringe barrel was found damaged before use.After removing t from the packaging and using the syringe to inject, it "scratched" the nurse's hand.The following information was provided by the initial reporter, translated from chinese to english: "when the nurse used a pre-filled catheter flusher to indwell the needle to seal the tube, the package was unpacked and the appearance of the syringe was damaged.It was difficult for the nurse to fix and scratch the skin of the hand when injecting.".
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