There has been a previous report received with a similar device where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.Investigation results: as per service engineer- (b)(4) - head cap -problem; (b)(4)-cartridge- problem; (b)(4) - neck- problem; under warranty invoice no.(b)(4) dated 01-30-2023.Problem investigation- cartridge neck and cap defective- replaced cartridge, head cap, neck.
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