MAUDE Adverse Event Report: ORGANON & CO. JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Thrombosis/Thrombus (4440)

Event Date 09/04/2023

Event Type  Injury  

Manufacturer Narrative

Based on the information we have received, there is no indication that the device malfunctioned.The device is assembled according to specifications.In process and finished product testing are performed and approved prior to release.

Event Description

The jada system then "seemed to be working, however then the patient started bleeding again" [device ineffective].Issues with the suction [device issue].Case narrative: this spontaneous report originating from the united states was received from a nurse via clinical account specialist (cas), referring to a 23-year-old female patient.The patient's medical history included singleton pregnancy and a live birth.Prior to her latest delivery her other laboratory tests (unspecified) were normal, and she presented frequently about a month prior to delivery with a complaint of "leaking fluid" but it could never be confirmed.On (b)(6) 2023, the patient was presented for an unscheduled caesarean section at 38 weeks gestation for fetal tachycardia.It was her second birth.During the caesarean section, blood loss was 600 ml.Two hours after caesarean section, patient suddenly lost 2500 ml of blood.The physician had already left the facility, so the nurses initiated protocol with uterotonics, methylergometrine maleate (methergine), carboprost trometamol (hemabate) and misoprostol (cytotec) (considered as concomitant medications).Her current conditions also included hospitalization, lower uterine segment atony, disseminated intravascular coagulation (dic) and mild anemia prior to delivery.Her past drugs/ allergies were not reported.This report concerns 1 patient and 1 device.On the same day, the patient was placed with vacuum-induced hemorrhage control system (jada system) via intrauterine route for postpartum hemorrhage by the nurses in the patient room.Reportedly, it was the operator's first time using the device and the device came with a blue seal valve.Field cas stated that there were "issues with the suction" (device issue).Reportedly, the device seemed to be working, however then the patient started bleeding again (device ineffective).The patient was transported to the operating room (or) off suction and hooked up to "neptune" (suction system in operating room), however, the vacuum-induced hemorrhage control system (jada system) didn't seem to work with "neptune".In the operating room, the patient's uterus was found to have "areas of bleeding which required stitching and cautery".Fundal height decreased some, but never got firm.An ultrasound was performed which noted fluid/clots.The vacuum-induced hemorrhage control system (jada system) was replaced with a new device at that time and 300 ml was returned into the suction canister.Another ultrasound was performed which did not note any fluid/ clots.Reportedly, this new vacuum-induced hemorrhage control system (jada system) (#2) controlled the bleeding.Patient received 3 units packed red blood cells (prbc) prior to transport, which could not be done via ground transport due to suction regulator limitations on the ambulance (110 mmhg was the lowest).Patient remained intubated and was airlifted to intensive care unit (icu) of an unknown facility (considered as hospitalization prolonged).Reportedly, the vacuum-induced hemorrhage control system (jada system) (#2) was switched out to a 3rd device while at the new facility for an unknown reason.No further information was known regarding use of vacuum-induced hemorrhage control system (jada system) at the new facility.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not provided.Upon internal review, the events of device issue and device ineffective were considered to be serious due to required interventions.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): 4607 hospitalization or prolonged hospitalization (hospitalization or prolonged hospitalization due to the health damage accompanying the use of device).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).Fda code: (health effects -health impact per annex f): 4643 blood transfusion (patient required an infusion of whole blood or a blood component directly into the bloodstream).

Event Description

The jada system then "seemed to be working, however then the patient started bleeding again" [device ineffective].Issues with the suction [device issue].Clots/fluid were noted during the ultrasound with jada(1) [device occlusion].Case narrative: this spontaneous report originating from the united states was received from a nurse via clinical account specialist (cas), referring to a 23-year-old female patient.The patient's medical history included singleton pregnancy and a live birth.Prior to her latest delivery her other laboratory tests (unspecified) were normal, and she presented frequently about a month prior to delivery with a complaint of "leaking fluid" but it could never be confirmed.On (b)(6) 2023, the patient was presented for an unscheduled caesarean section at 38 weeks gestation for fetal tachycardia.It was her second birth.During the caesarean section, blood loss was 600 ml.Two hours after caesarean section, patient suddenly lost 2500 ml of blood.The physician had already left the facility, so the nurses-initiated protocol with uterotonics, methylergometrine maleate (methergine), carboprost trometamol (hemabate) and misoprostol (cytotec) (considered as concomitant medications).Her current conditions also included hospitalization, lower uterine segment atony, disseminated intravascular coagulation (dic) and mild anemia prior to delivery.Her past drugs/ allergies were not reported.This report concerns 1 patient and 1 device.On the same day, the patient was placed with vacuum-induced hemorrhage control system (jada system) via intrauterine route for postpartum hemorrhage by the nurses in the patient room.Reportedly, it was the operator's first time using the device and the device came with a blue seal valve.Field cas stated that there were "issues with the suction" (device issue).Reportedly, the device seemed to be working, however then the patient started bleeding again (device ineffective).The patient was transported to the operating room (or) off suction and hooked up to "neptune" (suction system in or), however, the vacuum-induced hemorrhage control system (jada system) didn't seem to work with "neptune".In the or, the patient's uterus was found to have "areas of bleeding which required stitching and cautery".Fundal height decreased some, but never got firm.An ultrasound was performed which noted fluid/clots.The vacuum-induced hemorrhage control system (jada system) was replaced with a new device at that time and 300 ml was returned into the suction canister.Another ultrasound was performed which did not note any fluid/ clots.Reportedly, this new vacuum-induced hemorrhage control system (jada system) (#2) controlled the bleeding.Patient received 3 units packed red blood cells (prbc) prior to transport, which could not be done via ground transport due to suction regulator limitations on the ambulance (110 mmhg was the lowest).Patient remained intubated and was airlifted to intensive care unit (icu) of an unknown facility (considered as hospitalization prolonged).Reportedly, the vacuum-induced hemorrhage control system (jada system) (#2) was switched out to a 3rd device while at the new facility for an unknown reason.No further information was known regarding use of vacuum-induced hemorrhage control system (jada system) at the new facility.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not provided.Upon internal review, the events of device issue and device ineffective were considered to be serious due to required interventions.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): 4607: hospitalization or prolonged hospitalization (hospitalization or prolonged hospitalization due to the health damage accompanying the use of device).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).Fda code: (health effects health impact per annex f): 4643: blood transfusion (patient required an infusion of whole blood or a blood component directly into the bloodstream).Follow up information was received from a nurse on 20-sep-2023.On (b)(6) 2023, clots/fluid were noted during the ultrasound with vacuum-induced hemorrhage control system (jada system) (#1) (device occlusion) and caused prolongation of hospitalization, however it was not specified whether it was the reason for device did not work as reported.It was reported that vacuum-induced hemorrhage control system (jada system) (#2) worked appropriately and was placed in the operating room (or) after uterus was repaired and the reason for replacement of vacuum-induced hemorrhage control system (jada system) (#2) to vacuum-induced hemorrhage control system (jada system) (#3) was unknown as it was placed at the outlying hospital.No details were available regarding use of vacuum-induced hemorrhage control system (jada system) (#3) which was placed at outlying hospital.It was reported that suction pressure was unknown by the reporter for the devices and the fluid amount inserted into cervical seal for vacuum-induced hemorrhage control system (jada system) (#1) and (#2) were unknown by reporter (not reported).There was no mention of a membrane sweep.There was no known information from outlying hospital.The lot numbers for all the devices were unknown.No further details on vacuum-induced hemorrhage control system (jada system) (#1) working and suction issue.The reporter asked whether fluid removed prior to removing of vacuum-induced hemorrhage control system (jada system) or the fluid in the cervical seal or blood removed from the uterus was the fluid referring to the questionnaire.Upon internal review, the event device occlusion was considered to be serious due to required intervention.Medical device reporting criteria: serious injury.Fda code: (health effects: health impact per annex f): 4607: hospitalization or prolonged hospitalization (hospitalization or prolonged hospitalization due to the health damage accompanying the use of device).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).Fda code: (health effects: health impact per annex f): 4643: blood transfusion (patient required an infusion of whole blood or a blood component directly into the bloodstream).

Manufacturer Narrative

Based on the information we have received, there is no indication that the device malfunctioned.The device is assembled according to specifications.In process and finished product testing are performed and approved prior to release.

• Brand Name: JADA SYSTEM
• Type of Device: INTRAUTERINE VACUUM CONTRACTION SYSTEM
• Manufacturer (Section D): ORGANON & CO.; 30 hudson street; jersey city NJ 07302
• Manufacturer (Section G): ORGANON & CO.; 30 hudson street; jersey city NJ 07302
• Manufacturer Contact: 30 hudson street; jersey city, NJ 07302
• MDR Report Key: 17789972
• MDR Text Key: 324013902
• Report Number: 3002806821-2023-00111
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510K K201199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CYTOTEC (MISOPROSTOL),; CYTOTEC (MISOPROSTOL),; HEMABATE (CARBOPROST TROMETAMOL),; HEMABATE (CARBOPROST TROMETAMOL),; METHERGINE (METHYLERGOMETRINE MALEATE),; METHERGINE (METHYLERGOMETRINE MALEATE),
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 23 YR
• Patient Sex: Female