A product investigation was conducted.Visual inspection: upon visual inspection, it was observed that only the hydraulic pump was returned from the confidence kit and there was some moisture observed inside the pump.No other issues were identified with the returned device.Functional test: the functional test cannot be performed on the returned device as the hydraulic pump was returned by itself.Dimensional inspection: a dimensional inspection was not performed as the internal components were inaccessible without destruction of the device.Document/specification review: based on the date of manufacture the relevant drawings, reflecting the current and manufactured revision were reviewed yes, the device received was leaking.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the confidence kit, no needles (p/n: 283913000, lot #: 244229).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history record (dhr) review was conducted: the dhr of product code 283913000, lot 244229, was reviewed and no non-conformances were observed during the manufacturing process.The product was released on june 11th, 2019.Qty.(b)(4).The dhr was electronically reviewed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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