(b)(4).A visual examination of the returned complaint device revealed that the gauge needle indicated 0 atm.It was noted that the allance syringe was received with its extension tube.Functional evaluation was performed, and the device was pressurized using 35 ml of sterile water; no issues wer observed.An attempt was made to pressurize the device to 10 atm with 35 ml of water for 30 seconds and no issues were noted with the gauge needle during functional analysis.As there were no issue with the functional and visual test during product analysis, the complaint issue cannot be confirmed.The most probable root cause of the reported 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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