Based on the information provided, no conclusion can be made.As reported, after use the arista ah clogged the surgical drain, and the drain was removed prematurely (2-3 days post op).The doctor does not recall removing/irrigating any of the residual arista powder after application.The warning section of the instruction for use supplied with this device states, " once hemostasis is achieved, excess arista" ah should be removed from the site of application by irrigation and aspiration" and also states, "arista" ah swells to its maximum volume immediately upon contact with blood or other fluids.Dry, white arista" ah should be removed." no lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event is consider to be a best estimate as (b)(6) 2021 based on date of awareness.Should additional information be provided, a supplemental mdr will be submitted.
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As reported, during a mastectomy case the surgeon used a bard/davol arista ah hemostatic agent, prior to closing the patient it was noticed that the patients surgical drain had a decreased output.It was reported that the surgeon does not recall removing/irrigating any of the residual arista powder after application.As reported, the drain was removed prematurely (about 2-3 days post op) vs the usual one week.It was reported that the drain being removed early was not an issue as the patient had 2 drains placed after that case.There was no reported patient injury.
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