Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: n/a.Investigation results: summary: investigation summary: customer returned (1) 3/10 cc, 8 mm, 31 g syringe in an open poly bag from lot # 6179832.Customer states that the plunger rod was difficult to move.The returned syringe was tested and the plunger rod was able to be exercised in the barrel without any observed defects.A review of the device history record was completed for batch # 6179832 all inspections were performed per the applicable operations qc specifications.There were five (5) notifications (b)(4) noted that did not pertain to the complaint.Conclusion: based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure 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.Based on the above, no additional investigation and no capa is required at this time root cause: root cause cannot be determined at this time as the issue is unconfirmed.
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