(b)(4).Investigation results: visual examination of the complaint device found that there was a white stain on the side of the device, inside the clear housing and on the outside of the barrel.The stain did not obstruct the graduation marks in the barrel.The stain is consistent with residues of dried adhesive used during the automated manufacturing process.The most probable root cause is manufacturing deficiency, as the design or validation of a suppliers manufacturing process was not sufficient to ensure the finished device met the intent of the design.An investigation to address this issue has been completed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
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It was reported to boston scientific corporation that an encore inflation device was used in the bile duct during a biliary dilation procedure performed on (b)(6) 2019.According to the complainant, during preparation, a dirt was noticed in the inner tube of the inflator.The procedure was completed with another encore inflation device.There were no patient complications reported as a result of this event.
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