Jada system was discontinued because they thought is wasn't working properly [device ineffective].There was bleeding around the cervical seal [device leakage].Per nurse jada system was not suctioning [device issue].I think it was a placement issue [device placement issue].Case narrative: this spontaneous report originating from united states as received from registered nurse (from a nursing staff undergoing in-service) via clinical educator, referring to a female patient of unknown age.The patient's concurrent conditions and drug reactions / allergies were not reported.The patient's medical history included pregnancy and delivery.The patient's concomitant medications included unspecified uterotonic drug.There was no maternal admission to intensive care unit (icu).This report concerned 1 patient and 1 device.On an unknown date in august 2022, the patient underwent vacuum-induced hemorrhage control system (jada system) (1.0) placement via vaginal route (lot# and expiration date were not reported for postpartum bleeding (postpartum hemorrhage).After placement, the same day of insertion at unknown time, there was a bleeding around the cervical seal (device leakage) and was disconnected and the vacuum-induced hemorrhage control system (jada system) was not suctioning according to nurse (device issue).The reporting nurse was unsure if it was inflated enough or how much fluid was used.The vacuum-induced hemorrhage control system (jada system) was discontinued (removed) as it was not working properly and did not stop control the bleeding (device ineffective), and another unspecified uterine tonic was used.The vacuum-induced hemorrhage control system (jada system) did not break (the plastic breaks apart) nor it was difficult to connect or lost connection.It was reported that the patient sought medical attention.The reporter reported that she did not think it was a quality issue and thought it was a placement issue (device placement issue).The clinical educator was unable to obtain any additional information.No additional adverse event (ae)/ product quality complaint (pqc) reported.No additional information provided.No further information provided.For vacuum-induced hemorrhage control system (jada system), the lot number and the serial number was not available.Upon internal review, device ineffective was determined to be medically significant.Medical device reporting criteria: serious injury.Fda code: (health effects - health impact per annex f): 4641 unexpected medical intervention (patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan).
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