Investigation summary: customer returned a photo of 1cc syringes.Customer states that the barrel is curved.The photo was examined and exhibited bowed barrels.A review of the device history record was completed for batch# 7353805.All inspections were performed per the applicable operations qc specifications.There were seven (7) notifications [200732851, 200732817, 200733433, 200732638, 200732795, 200732871, 200732939] noted that did not pertain to the complaint.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was 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.Possible root cause: molding - processing issue (parts were blocked and associate didn't back off the plastic infeed, water problems, overpacking, etc.) material handling (duration of components being stored in totes).
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