Couldn't get the air out of the cervical seal [device defective].No additional ae reported, no pqc reported.[no adverse event].Case narrative: this spontaneous report originating from united states was received from a physician via clinical account specialist (cas) referring to a female patient of unknown age.The patient's medical history, past drugs or allergies, and concomitant medications were not reported.This report concerns 1 patient(s) and 1 device(s).Approximately in february 2024 (reported as sometime last week), the patient underwent insertion with vacuum-induced hemorrhage control system (jada system) (lot # and expiration date were not reported) via vaginal route for an unknown indication.The clinical account specialist (cas) reporting on behalf of the physician.Approximately in february 2024 (reported as sometime last week), the clinical account specialist (cas) reported that the physician put the luer-lock syringe in to deflate the vacuum-induced hemorrhage control system (jada system) and could not get the air out of the cervical seal (device defective).The physician obtained a second vacuum-induced hemorrhage control system (jada system) to use, and it worked just fine.The physician told staff to set the defective vacuum-induced hemorrhage control system (jada system) aside, but they did not.The clinical account specialist (cas) did not have any patient or product information to report and had no further details to provide.The physician only wanted to be contacted by email.The physician was requesting a replacement.No other adverse event (ae)/product quality complaint (pqc) reported (no adverse event).Vacuum-induced hemorrhage control system (jada system) was not broken (i.E., the plastic break apart).It was difficult to connect/lost connection during preparation.More than one vacuum-induced hemorrhage control system (jada system) device was used as the first one did not work.The operator of the device was attending physician.Therapy with vacuum-induced hemorrhage control system (jada system) was withdrawn.The outcome of events was unknown.Upon internal review, the event device defective was considered to be medically significant.When the lot number is unknown, a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.Medical device reporting criteria: malfunction.
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