Investigation summary: one photo was provided.The photo shows the barrel flange damaged, therefore failure mode is verified.This type of damage most likely was induced by a process variation of the plunger rod label machine.Adjustments to the machine were done and preventive maintenance implemented.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.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Investigation conclusion: this is the 1st complaint for lot # 8019579 for this type of defect or symptom.There was no documentation for this type of defect during the entire production run of this batch.Root cause description: this type of damage most likely was induced by a process variation of the plunger rod label machine rationale: adjustments to the machine were done and preventive maintenance implemented.
|