Results: as previously reported, a sample is not available for evaluation.However, on 12/16/2016, the customer provided two photos of the affected device.A photo inspection revealed the needle was partially retracted into the safety barrel leaving the needle tip exposed.Damage was observed on the grip the unit.The damage was facing inward and in the area at the bottom of the grip where it connects to the barrel.Conclusion: our quality engineer has determined that based off of the returned photos, the root cause for this incident is related to the manufacturing process.The plug probe and the load barrel stations in zone 5 have the ability to become misaligned and produce the type of damage observed in the returned photos.When there is a misalignment, the probe inadvertently contacts the edge of the grip and causes the damage observed in the complaint sample.A formal corrective action will not be initiated at this time.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.Manufacturing was notified of this incident and the findings.
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