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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 Insufficient Information (4580)
Event Date 08/02/2023
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
Jada was placed in the operating room, but it did not control the bleeding for the patient [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 condition included: on an unknown date in 2022, the patient had a singleton pregnancy.She was g2p2 (gravida 2 and para 2).She did not have invasive placenta, endometritis or disseminated intravascular coagulation (dic).On (b)(6) 2023, the patient had an induced vaginal birth, but it did not progress and hence the patient was taken to the operating room (considered as "hospitalization") to have an emergent cesarean section her current conditions included uterine atony (also reported as "the uterus was pale and not contracting").No blood products were required during peripartum period.Her past drugs/allergies and concomitant medications were not reported.This report concerns 1 patient and 1 device.On (b)(6) 2023, the patient was placed with vacuum-induced hemorrhage control system (jada system) via vaginal route (lot# and expiration date were not reported) for post partum hemorrhage (postpartum haemorrhage) by physician in the operating room.However, it did not control the bleeding for the patient, so it was removed (device ineffective) on the same day.Reportedly, 400 milliliter (ml) of blood was collected in the vacuum-induced hemorrhage control system (jada system) canister and a large baby clot came out with the device and when it was removed.The patient ended up having a hysterectomy that controlled the bleeding.Reportedly, the device came with a blue seal valve, kit and green carton.More than one device was not used.The device was not removed and then reinserted for any reason.An ultrasound was not used at any point to evaluate during vacuum-induced hemorrhage control system (jada system) use.Maternal admission to intensive care unit (icu) was not required.The suspected cause of the postpartum hemorrhage was reported as uterine atony.No other symptoms were reported for the patient, and at the time of time of reporting the patient had recovered.There was no patient overdose, and the adverse event was not cancer.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): 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.
 
Event Description
Jada was placed in the operating room, but it did not control the bleeding for the patient [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 condition included: on an unknown date in 2022, the patient had a singleton pregnancy.She was g2p2 (gravida 2 and para 2).She did not have invasive placenta, endometritis or disseminated intravascular coagulation (dic).On (b)(6) 2023, the patient had an induced vaginal birth, but it did not progress and hence the patient was taken to the operating room (considered as "hospitalization") to have an emergent cesarean section her current conditions included uterine atony (also reported as "the uterus was pale and not contracting").No blood products were required during peripartum period.Her past drugs/allergies and concomitant medications were not reported.This report concerns 1 patient and 1 device.On (b)(6) 2023, the patient was placed with vacuum-induced hemorrhage control system (jada system) via vaginal route (lot# and expiration date were not reported) for post partum hemorrhage (postpartum haemorrhage) by physician in the operating room.However, it did not control the bleeding for the patient, so it was removed (device ineffective) on the same day.Reportedly, 400 milliliter (ml) of blood was collected in the vacuum-induced hemorrhage control system (jada system) canister and a large baby clot came out with the device and when it was removed.The patient ended up having a hysterectomy that controlled the bleeding.Reportedly, the device came with a blue seal valve, kit and green carton.More than one device was not used.The device was not removed and then reinserted for any reason.An ultrasound was not used at any point to evaluate during vacuum-induced hemorrhage control system (jada system) use.Maternal admission to intensive care unit (icu) was not required.The suspected cause of the postpartum hemorrhage was reported as uterine atony.No other symptoms were reported for the patient, and at the time of time of reporting the patient had recovered.There was no patient overdose, and the adverse event was not cancer.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): 4624 surgical intervention (one or more surgical procedures was required, or an existing procedure changed).Follow-up information has been received from the physician on 09-aug-2023.Patient's demographics were updated, and she was reported to 29 years old.The physician reported that the vacuum-induced hemorrhage control system (jada system) was used after trying other methods to control the bleeding.Prior to using the vacuum-induced hemorrhage control system (jada system), the patient received oxytocin (pitocin), misoprostol (cytotec), tranexamic acid (txa), methylergometrine maleate (methergine) and carboprost trometamol (hemabate) (considered as concomitant medications) and sutures were placed as well in an attempt to stop the bleeding.The physician explained that pre-eclampsia, arrest of dilation, and a macrosomic baby contributed to the patient¿s uterine atony.She believed that the vacuum-induced hemorrhage control system (jada system) did all that it could and was helpful to control the patient¿s bleeding, but it was not going to fix complete uterine atony.The tone just never got there, so they had no choice but to do a hysterectomy which resolved the problem.The physician had no further information to provide regarding this case.
 
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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 Key17480778
MDR Text Key320608398
Report Number3002806821-2023-00096
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
Report Date 08/14/2023
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 Received08/08/2023
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received08/14/2023
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
CYTOTEC (MISOPROSTOL).; HEMABATE (CARBOPROST TROMETAMOL).; METHERGINE (METHYLERGOMETRINE MALEATE).; PITOCIN [OXYTOCIN] (OXYTOCIN).; TRANEXAMIC ACID (TRANEXAMIC ACID).
Patient Outcome(s) Required Intervention;
Patient Age29 YR
Patient SexFemale
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