H.6.Investigation summary: three photos and one loose syringe were received and visually evaluated.Based on the photos, the syringe was manipulated prior to arriving for evaluation.Photos depict unidentified liquid residue inside the barrel in the fluid path and on the stopper along with foreign matter particulate.The sample received had its stopper in the bottom out position.Upon inspection of the syringe, foreign matter was observed in the fluid path between the stopper and the bottom of the barrel.The foreign matter was a large brown particle, larger than level 2 in size.The foreign matter was wet with unidentified liquid residue inside the barrel.No further evaluation could be performed due to potential risk associated with handling the sample.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.The potential root cause for the foreign matter defect cannot be determined based on photos and the sample provided.The sample was received manipulated, not in its original packaging.Therefore, based on the available information it is not possible to conclude the defect was caused by a manufacturing process.The defect could not be confirmed to have originated at the manufacturing plant.
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