Initial reporter addr 1: (b)(6).Investigation summary: there was no sample or photo provided to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.A device history record review found no non-conformances associated with this issue during production of this batch.Though the incident could not be confirmed based on this complaint, bd is aware of this issue and is in the process of implementing corrective actions to improve the customer and patient experience.This event has been added to our complaint database.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: as no sample and no photo was returned, a review of past 12 months quality notification was performed.No similar quality notification was raised for the reported defect.Based on the verbatim, the probable root cause for the reported condition of this complaint could be due to valve issue that was related to eto sterilization.Capa#(b)(4) and product recall was initiated for vps product sterilized using eto.Complaint trend would be monitored.Complaint will be reopened when sample is returned.
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It was reported that the bd venflon" pro safety shielded iv catheter experienced blood backflow during blood draw.The following information was provided by the initial reporter: blood leaking from injection port, in keeping with safety notice from manufacturer, cannula removed.
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