She still could not place/physician was unable to insert the jada [complication of device insertion] she did try using ring forceps [wrong technique in device usage process] the patient was not dilated to 3 centimeters, she was probably only at 1 centimeter when they tried to insert the jada [contraindicated device used].Case narrative: this spontaneous report was received from a nurse via clinical sales educator (cse) referring to a female patient of unknown age.The patient had singleton pregnancy and had a scheduled cesarean delivery.Gestational age at delivery was mentioned as term.Spinal anaesthesia was used during delivery.There was no invasive placenta.The patient had no previous history of abnormal postpartum uterine bleeding or hemorrhage.The patient's concurrent condition included obesity, hypertension (htn), asthma and lower uterine segment atony.Patient was gravida 5 and para 5.The patient also required 2 units of blood during the peripartum period.Maternal intensive care united (icu) was not required and patient was not diagnosed with endometritis.The patient was given oxytocin prior to use of vacuum-induced hemorrhage control system (jada system).This report concerns 1 patient and 1 device.On (b)(6) 2023, a resident physician attempted to place vacuum-induced hemorrhage control system (jada system) (route, lot# and expiration date were not reported) for uterine bleeding (uterine haemorrhage).She felt that it was floppy when trying to insert.She said it would be much easier if there was something that held the loop closed, like the plastic sleeve that covers the intrauterine pressure catheter (iupc) that could be removed once the device is inserted.She did try that using ring forceps to help but she still could not place (wrong technique in device usage process).She was trying to place because meds cannot be given due to contraindications.In addition, it was also stated that the patient was not dilated to 3 centimeters, she was probably only at 1 centimeter when they tried to insert the vacuum-induced hemorrhage control system (jada system) (contraindicated device used).The physician did state that she knew the patient was supposed to be dilated to 3 centimeters for vacuum-induced hemorrhage control system (jada system) use.It was also reported that the patient lost 2 liters of blood and the physician was unable to insert the vacuum-induced hemorrhage control system (jada system) (complication of device insertion), they ended up inserting a bakri uterine balloon.Reporter believed that vacuum-induced hemorrhage control system (jada system) came with a blue seal valve, kit, no irregular shape noticed when the packet was first opened, there was no damage noted to the carton or tray, shape of the loop was normal.No ultrasound was used at any point to evaluate during vacuum-induced hemorrhage control system (jada system) use.The device was stored in an office prior to use.No additional adverse event (ae) or product quality complaint (pqc) reported.Upon internal review, the event of "complication of device insertion and wrong technique in device usage process " were determined to be serious due to required intervention.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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