E.1 initial reporter phone #: (b)(6).H.6 investigation summary: it was reported there was a green strip of foreign matter over the rubber stopper.To aid in the investigation, one empty sample in an opened packaging flow wrap and one photo was provided for evaluation by our quality team.A visual inspection was performed, and the syringe rubber stopper has a piece of green rubber material 1/2" long.The photo provided shows the sample received.No other defects or imperfections were observed.This defect could occur if a piece of rubber material from the equipment became loose and ended up in the syringe.A device history record review was completed for provided material number 306593, lot 2096908.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.The sample will be shown to the associates for awareness.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.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.H3 other text : see h.10.
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It was reported that the bd pre-filled normal saline syringe experienced foreign matter, contaminated.The following information was provided by the initial reporter, translated from chinese to english: the matron reported that the green strip foreign matter was found stuck on the rubber plug when the package was not opened green claim requires a response letter samples can be returned with photos.
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