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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORGANON & CO. JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM
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ORGANON & CO. JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Type  Injury  
Event Description
Provider reported that the jada ¿did help with tone,¿ but when the provider ¿started seeing more blood in the canister [device ineffective].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 conditions included pregnancy and delivery.She developed uterine atony post-delivery.Her past drugs/allergies and concomitant medications were not reported.This report concerns 1 patient and 1 device.On an unknown date, the patient was placed with vacuum-induced hemorrhage control system (jada system) via intrauterine route for bleeding control by the attending physician.The device did help with the tone, however, when the provider "started seeing more blood in the canister" (device ineffective) (the device did not control the bleeding), the provider decided to embolize the uterine artery of the patient.Reportedly, no interventions were given prior to vacuum-induced hemorrhage control system (jada system).More than one device was not used, and it was not provider's first time using the device.The device was not removed and then reinserted due to any reason.The suspected cause of postpartum hemorrhage was uterine bleeding.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.For vacuum-induced hemorrhage control system (jada system), the lot number and the serial number were not available.Upon internal review, the event of device ineffective was considered as serious due to the required intervention.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: 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).
 
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
Provider reported that the jada ¿did help with tone,¿ but when the provider ¿started seeing more blood in the canister [device ineffective] 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 conditions included pregnancy and delivery.She developed uterine atony post-delivery.Her past drugs/allergies and concomitant medications were not reported.This report concerns 1 patient and 1 device.On an unknown date, the patient was placed with vacuum-induced hemorrhage control system (jada system) via intrauterine route for bleeding control by the attending physician.The device did help with the tone, however, when the provider "started seeing more blood in the canister" (device ineffective) (the device did not control the bleeding), the provider decided to embolize the uterine artery of the patient.Reportedly, no interventions were given prior to vacuum-induced hemorrhage control system (jada system).More than one device was not used, and it was not provider's first time using the device.The device was not removed and then reinserted due to any reason.The suspected cause of postpartum hemorrhage was uterine atony.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.For vacuum-induced hemorrhage control system (jada system), the lot number and the serial number were not available.Upon internal review, the event of device ineffective was considered as serious due to the required intervention.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: 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).Follow-up information was received from the physician on 29-aug-2023.The physician reported that she was the backup doctor so by the time she got to the patient, the patient had already bleed 1800 cubic centimeter (cc) and that she had delivered vaginally.Prior to the device placement, the physician had used tranexamic acid (txa) and oxytocin (pitocin) at unknown doses, and evacuated the uterus, then placed the device.Additionally, the device seemed to work initially, but then there was more bleeding than expected and gave additional uterotonics (unspecified) which again the patient responded initially but then continued to bleed.After about 2 liters of blood loss the device was removed and a uterine artery ligation was performed.The patient did not go the intensive care unit, and no additional interventions were performed.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: serious injury.Fda code: (health effects - health impact per annex f): 4624 surgical intervention (one or more surgical procedures was required, or an existing procedure changed).
 
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.
 
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
Provider reported that the jada ¿did help with tone,¿ but when the provider ¿started seeing more blood in the canister [device ineffective] 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 conditions included pregnancy and delivery.She developed uterine atony post-delivery.Her past drugs/allergies and concomitant medications were not reported.This report concerns 1 patient and 1 device.On an unknown date, the patient was placed with vacuum-induced hemorrhage control system (jada system) via intrauterine route for bleeding control by the attending physician.The device did help with the tone, however, when the provider "started seeing more blood in the canister" (device ineffective) (the device did not control the bleeding), the provider decided to embolize the uterine artery of the patient.Reportedly, no interventions were given prior to vacuum-induced hemorrhage control system (jada system).More than one device was not used, and it was not provider's first time using the device.The device was not removed and then reinserted due to any reason.The suspected cause of postpartum hemorrhage was uterine atony.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.For vacuum-induced hemorrhage control system (jada system), the lot number and the serial number were not available.Upon internal review, the event of device ineffective was considered as serious due to the required intervention.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: 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).Follow-up information was received from the physician on 29-aug-2023.The physician reported that she was the backup doctor so by the time she got to the patient, the patient had already bled 1800 cubic centimeter (cc) and that she had delivered vaginally.Prior to the device placement, the physician had used tranexamic acid (txa) and oxytocin (pitocin) at unknown doses, and evacuated the uterus, then placed the device.Additionally, the device seemed to work initially, but then there was more bleeding than expected and gave additional uterotonics (unspecified) which again the patient responded initially but then continued to bleed.After about 2 liters of blood loss the device was removed and a uterine artery ligation was performed.The patient did not go the intensive care unit, and no additional interventions were performed.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: serious injury.Fda code: (health effects - health impact per annex f): 4624 surgical intervention (one or more surgical procedures was required, or an existing procedure changed).Follow-up information was received from the physician on 30-aug-2023.It was reported that the physician did not think that the patient had a history of postpartum bleeding.Her latest pregnancy was singleton which she delivered at term, and she did not undergo forceps assisted vaginal delivery.2 units of packed red blood cells (rbcs) were used during the peripartum period.There was no diagnosis of invasive placenta, endometritis, hyperglycaemia or disseminated intravascular coagulation (dic).Reportedly, the device did control the bleeding at first then 15 minutes later, the bleeding continued.Around 300 ml of blood was collected into the vacuum-induced hemorrhage control system (jada system)'s canister, and the total duration of device usage was around 3 hours (reported as "maybe").The physician received training on how to use vacuum-induced hemorrhage control system (jada system) in 2022 (reported as "maybe a year ago").An ultrasound was not used at any point to evaluate during the device use, and maternal admission to intensive care unit (icu) was not required.
 
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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 Key17631018
MDR Text Key322040095
Report Number3002806821-2023-00101
Device Sequence Number1
Product Code OQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
510K K201199
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 08/31/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/28/2023
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received08/30/2023
08/31/2023
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 Number1
Treatment
PITOCIN [OXYTOCIN] (OXYTOCIN),; PITOCIN [OXYTOCIN] (OXYTOCIN),; TRANEXAMIC ACID (TRANEXAMIC ACID),; TRANEXAMIC ACID (TRANEXAMIC ACID),
Patient Outcome(s) Required Intervention;
Patient SexFemale
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