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

Model Number	JADA-2002
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporting information indicated that 120 ml was put in the cervical seal and only 80 ml was removed via a syringe.This suggests that there is a potential leakage from the cervical seal.However, root cause of the cervical seal leakage cannot be investigated and confirmed since the jada system was discarded.This is default text configured for block h10.
Event or Problem Description
They noticed a watery blood-tinged leakage [device leakage].No additional ae/pqc reported.[no adverse event].Case narrative: this spontaneous report originating from united states was received from the nurse manager referring to female patient via clinical account specialist.The patient medical history, concurrent condition, past drug allergy and concomitant medication was not reported.This report concerns 1 patient(s) and 1 device(s).On an unknown date, the patient was placed with vacuum-induced hemorrhage control system (jada system) 2.0 via intravaginal route (defaulted) (lot #, serial # and expiration date was not reported) for an unknown indication.On an unknown date, vacuum-induced hemorrhage control system (jada system) was suspected to be leaking.As per the clinical account specialist 120 ml was put in the cervical seal and they noticed a watery blood-tinged leakage (device leakage).Only 80 ml was removed via a syringe.The vacuum-induced hemorrhage control system (jada system) was discarded.No additional adverse event (no adverse event)/product quality complaint (pqc) was reported.Case comments: based on the clinically relevant information currently available for this individual case and the assessment per us decision tree (device only), the case was considered not reportable, since the information did not reasonably suggest that the product may have caused/contributed to or likely to cause/contribute to death or any of the other serious injuries/outcomes or needed any additional medical or surgical intervention beyond what is normally required.
Additional Manufacturer Narrative
Reporting information indicated that 120 ml was put in the cervical seal and only 80 ml was removed via a syringe.This suggests that there is a potential leakage from the cervical seal.However, root cause of the cervical seal leakage cannot be investigated and confirmed since the jada system was discarded.This is an amendment report: the adverse event checkbox was unchecked in medwatch info sub tab.This case has been downgraded after further review and no longer meets criteria for a device reportable event.The malfunction checkbox was incorrectly selected earlier and would be updated correctly after this one last submission.This is default text configured for block h10.
Event or Problem Description
This is an amendment report: the adverse event checkbox was unchecked in medwatch info sub tab.This case has been downgraded after further review and no longer meets criteria for a device reportable event.The malfunction checkbox was incorrectly selected earlier and would be updated correctly after this one last submission.

• 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: 23706014
• Report Number: 3002806821-2025-00080
• Device Sequence Number: 10691683
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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
• Operator of Device: Health Professional
• Device Model Number: JADA-2002
• 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: 12/03/2025
• Supplement Report FDA Received Date: 01/09/2026
• 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
• Patient Sex: Female