(b)(4).Investigation results: an interject needle was returned for analysis.A visual evaluation of the returned device revealed that there were no visual defects noted, the returned device looks under good conditions without evidence of damages.No other anomalies were noted.Functional evaluation with the working length formed into two 2¿ diameter loops found the needle would extend and retract without issue.The handle operation was smooth when actuating the device.A second functional inspection was performed, a spare lab syringe was filled with water, several attempts to inject the water were made but they were unsuccessful, the water did not come out from the needle tip.The device was disassembled and an occlusion was found blocking the inner sheath at the proximal side of the needle.Based on the information available and the analysis performed the complaint will be documented as "manufacturing execution error", the manufacturing process was not executed as validated/as designed.There is an investigation to address this issue.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
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