Jada hooked up to suction on a patient but there¿s a clot in jada [device occlusion] we looked on the program and can¿t see any directions on how to flush a clot out of the jada without it going back up into the bulb.Device issue.Case narrative: this spontaneous report originating from united states was received from a registered nurse via (b)(6) referring to a female patient of unknown age.The patient's concurrent conditions, concomitant medications, medical history, and past drug reactions/allergies were not reported.This report concerned 1 patient and 1 device.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system (jada system) for an unknown indication which had a clot in it due to which vacuum-induced hemorrhage control system (jada system) was hooked up to suction (device occlusion) and vacuum-induced hemorrhage control system (jada system) needs to be flushed but was unable to locate instructions regarding how to flush a clot out of the vacuum-induced hemorrhage control system (jada system) without going back up into the bulb (device issue).No additional adverse event was captured as the nurse was actively treated the patient.For vacuum-induced hemorrhage control system (jada system), the lot number was not available and the serial number was not available.The vacuum-induced hemorrhage control system (jada system) was available for evaluation.Upon internal review, the event of device occlusion was determined to be medically significant.When the lot number is unknown, a technical investigation of the specific manufacturing process which includes review of records associated with a known lot number cannot be performed.Therefore, priority quality investigation will not be completed.Medical device reporting criteria: serious injury.Fda code: (health effects - health impact per annex f): 4648 insufficient information (there is not yet enough information available to classify the health impact).
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