Review of the dhr revealed all required challenges samples and testing was performed per specification in accordance with the in-process sampling plans.Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.The peura (end user risk analysis) was analyzed to determine the risk to customer.The analysis showed that due to low occurrence, current risk is acceptable.Samples were received for evaluation by our quality engineer team.They received 11 unused iag 22ga units in sealed packages from the lot number 7261882.The actual unit described in the incident report was not returned for evaluation.Visual/microscopic examination showed there was no mechanical/physical damage to any of the components (spring, needle hub, or grips) or evidence of adhesive on the buttons or hubs.Functional test (needle retraction) was performed and showed the retraction was successful, no delayed reaction was observed.The returned units provided for evaluation met and performed per the required manufacturing specifications.As there was no definite physical or mechanical evidence that supported manufacturing process related issues for the defect observed in this incident, a root cause could not be determined.The defect needle retraction failure; as stated as the reported code was not confirmed with the returned unit.The returned unit did not display any adverse characteristics that would contribute to the defect the customer experienced, per the pir.A formal corrective action will not be initiated at this time.A manufacturing related root cause could not be identified.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.
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