(b)(4).Investigation result: a visual examination of the returned complaint device revealed that the gauge needle indicated 0 atm.Functional evaluation was performed, and the device was pressurized using 35 ml of sterile water; no issues were noted with the gauge needle during analysis.As there was no issue with the visual and functional test during product analysis, the complaint incident cannot be confirmed.Taking into consideration the evaluation conducted and the details of the complaint, the most probable root cause of this event cannot be detected.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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