Our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph which displayed the needle and shield from an insyte autoguard device.The catheter was not present on the needle.The needle appeared to be fully extended and no bends or damage were observed on the device.As the video played, it appeared that multiple attempts were made to activate the safety mechanism, but no movement of the needle could be observed.This report appeared to be likely manufacturing-related; however, without the physical sample, it could not be determined if the cause was related to excess adhesive, a bound spring, or other root cause.A device history record review showed no non-conformances associated with this issue during the production of this batch.However, a trend has been identified for the reported failure and corrective actions have been initiated to investigate this type of incident and identity the root cause.The appropriate personnel have been notified.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.
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