Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.However, the failure could have happened that when the plunger rod was to be assembled to the syringe the infeed scroll was not fully aligned inducing the damage to the plunger rod.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.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.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 # 9205548 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: it could have happened during the posiflush assembly process.Rationale: capa not required at this time.
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It was reported that the bd posiflush¿ normal saline syringe's plunger rod was found broken before use while opening up the packaging.The following information was provided by the initial reporter, translated from chinese to english: "when the nurse was changing the picc for patient , the prefilled catheter irrigator was prepared to flush the tube.While opening the outer package, it was found that the plunger rod was broken.".
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