MAUDE Adverse Event Report: ORGANON LLC JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

Model Number	JADA-2002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient's cervix was getting clogged with clots [device occlusion].Did the jada device stop control the bleeding? no, it was never controlled [device ineffective].No additional aes reported [no adverse event].Case narrative: this spontaneous report originating from united states was received from the office manager referring to a 35-year-old female patient.The patient's historical drugs included methylergometrine maleate (methergine), hemobate and misoprostol (rectal cytotec).The patient's obstetric history included multigravida (gravida 9) and multiparous (para 9).The patient's current pregnancy was a singleton, delivered via cesarean section due to breech presentation.Delivery was not induced.The patient had the estimated blood loss around 1000 ml.The blood products required during peripartum period and 2 units of products and volume was transfused.The suspected cause of the postpartum hemorrhage was uterine atony.The patient's allergies and concomitant medications were not reported.This report concerns 1 patient(s) and 1 device (s).On (b)(6) 2025, the patient was placed with vacuum-induced hemorrhage control system (jada system) via transvaginal route (lot #, serial # and expiration date were not reported) for postpartum hemorrhage.The green part that went into the patient's cervix was getting clogged with clots (device occlusion) and had to use second vacuum-induced hemorrhage control system (jada system) because of the clots and the clogging (device ineffective).The patient was hospitalized approximately in (b)(6) 2025.The patient required admission to icu (intensive care unit) and the duration of icu admission was 1 day.The patient was not diagnosed with endometritis (infection of the uterus).Hysterectomy was done to control the abnormal postpartum uterine bleeding.300 ml blood was collected in the vacuum-induced hemorrhage control system (jada system) canister.The operator of the device was attending physician and operator received training on how to use vacuum-induced hemorrhage control system (jada system).The device was discarded and did not have device or carton.No additional adverse events (aes) reported (no adverse event).No product quality complaints (pqcs) reported.The reporter considered the device occlusion and device ineffective serious due to life threatening.Upon internal review, the events device occlusion and device ineffective was determined to be serious due to required intervention (devices).Medical device reporting criteria: serious injury.This is one of several reports received from the same reporter.
Additional Manufacturer Narrative
The model number information was not reported or not known by the reporter.Hence, we cannot definitively determine the model with the information provided.Model 2 was selected as there is a much higher probability that this model was used as organon is currently only manufacturing/marketing this model.This is default text configured for block h10.
Event or Problem Description
Follow-up information has been received from investigation department on 05-nov-2025.No complaint sample or device lot number were available for evaluation; therefore, an unknown investigation was performed.The device was assembled per specifications where in-process and final inspections are conducted by trained personnel.No outcome from the investigation could be determined since no complaint sample or lot identification has been provided.If the complaint sample or lot number become available, this complaint will be re-opened, and additional investigation may be performed.
Additional Manufacturer Narrative
The model number information was not reported or not known by the reporter.Hence, we cannot definitively determine the model with the information provided.Model 2 was selected as there is a much higher probability that this model was used as organon is currently only manufacturing/marketing this model.No complaint sample or device lot number are available for evaluation; therefore, an unknown investigation was performed.The device is assembled per specifications where in-process and final inspections are conducted by trained personnel.No outcome from the investigation could be determined since no complaint sample or lot identification has been provided.If the complaint sample or lot number become available, this complaint will be re-opened and additional investigation may be performed this is default text configured for block h10.

• Brand Name: JADA SYSTEM
• Common Device Name: INTRAUTERINE VACUUM CONTRACTION SYSTEM
• Manufacturer (Section D): ORGANON LLC; 30 hudson street; jersey city NJ 07302
• Manufacturer (Section G): ORGANON LLC; 30 hudson street; jersey city NJ 07302
• Manufacturer Contact: tara brolly ; 30 hudson street; jersey city, NJ 07302
• MDR Report Key: 23199414
• Report Number: 3002806821-2025-00077
• Device Sequence Number: 9989403
• Product Code: OQY
• UDI-Device Identifier: 00840164521139
• UDI-Public: 00840164521139
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K212757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: JADA-2002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 11/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 35 YR
• Patient Sex: Female