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

Model Number	JADA-2002
Medical Device Problem Codes	Break (1069); Fracture (1260); Inflation Problem (1310); Leak/Splash (1354); Mechanical Problem (1384); Infusion or Flow Problem (2964); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number has not been identified for this complaint.(currently identified as unknown) investigation of the event by the manufacturing site is ongoing.
Event or Problem Description
There was an issue with a jada" and they "could not fill up the jada via the port; it just leaked out and would not connect and fil [device leakage] , no other ae/pqc reported.No additional information provided.[no adverse event].Case narrative: this spontaneous report originating from united states was received from a registered nurse referring to a female patient of unknown age via territory manager.The patient's medical history included delivery and pregnancy.The patient's concurrent conditions, past drug reactions/allergies and concomitant medications were not reported.This report concerns 1 patient(s) and 1 device(s).On (b)(6) 2025, the hcp (health care professional) was attempted to place with vacuum-induced hemorrhage control system (jada system) 2.0 via vaginal route (lot #, serial # and expiration date was not reported) for postpartum hemorrhage.On (b)(6) 2025 (also reported as saturday morning), there was an issue with a vacuum-induced hemorrhage control system (jada system) and hcp could not fill up the vacuum-induced hemorrhage control system (jada system) via the port; it just leaked out and would not connect and fill (device leakage).The vacuum-induced hemorrhage control system (jada system) that did not work was discarded, and another vacuum-induced hemorrhage control system (jada system) was used successfully.No other adverse event (ae) reported (no adverse event).Upon internal review, the event device leakage was considered to be medically significant.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.
Additional Manufacturer Narrative
Lot number has not been identified for this complaint.(currently identified as unknown) investigation of the event by the manufacturing site is ongoing.
Event or Problem Description
This is an amendment report to update products tab - sub tab - preliminary comments section.
Additional Manufacturer Narrative
Lot number has not been identified for this complaint.(currently identified as unknown) investigation of the event by the manufacturing site is ongoing.This is default text configured for block h10.
Event or Problem Description
This is an amendment report: added reference type of cr case#.Updated as reported causality of no adverse event from unknown to not assessed.
Additional Manufacturer Narrative
Lot number has not been identified for this complaint.(currently identified as unknown) investigation of the event by the manufacturing site is ongoing.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.
Event or Problem Description
This is an amendment report: adverse event checkbox was unchecked.
Additional Manufacturer Narrative
Lot number has not been identified for this complaint.(currently identified as unknown) investigation of the event by the manufacturing site is ongoing.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.
Event or Problem Description
Follow up report received on 25-nov-2025.This is final report.Manufacturing statement: note: recorded in the parent record it was noted by the complaint handling unit (chu) that the ae qir record (b)(4) was not converted to an ae pqc combo due to the pqc record (b)(4) was already in a workflow of med device reportability assessment req.As such, the pqc record could be converted in that state.(b)(4) is a priority and device reportable.As reported in lead ep investigation (lepi) (b)(4); 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.
Additional Manufacturer Narrative
Lot number has not been identified for this complaint.(currently identified as unknown) investigation of the event by the manufacturing site is ongoing.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.
Event or Problem Description
Follow up information was received from quality investigation team on 05-dec-2025.This is a final report.Manufacturing statement: 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.

• 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: 22894712
• Report Number: 3002806821-2025-00071
• Device Sequence Number: 8896945
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: JADA-2002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 09/10/2025; 10/17/2025; 11/28/2025; 12/10/2025; 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Female