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	08/24/2023
Type of Reportable Event	Serious Injury
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.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 or Problem Description
Jada failed and had to escalate to uae [device ineffective] it was reported that the provider did not think it was a jada error but she thinks it was a user error and thinks she should have pumped up the suction to 90 mm hg instead of 80mm hg.[device use issue], no additional ae reported, no pqc reported [no adverse event].Case narrative: this initial spontaneous report originating from the united states, was received from clinical educator (ce) on behalf of physician referring to female patient of unknown age.The patient's medical history, drug reactions or allergies, current conditions and concomitant medications were 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 vaginal route (defaulted) (lot #, serial # and expiration date were not reported) for an unknown indication.Ce stated that provider sent her a case study document in which vacuum-induced hemorrhage control system (jada system) failed (device ineffective) and had to escalate to uterine artery embolization (uae).The physician did not think it was a vacuum-induced hemorrhage control system (jada system) error, but she thought it was a user error and thought she should have pumped up the suction to 90 millimeters of mercury (mmhg) instead of 80mmhg (device use issue).She stated moving forward she would have trouble shoot a little better.The vacuum-induced hemorrhage control system (jada system) was left in the entire time.No additional adverse event reported (no adverse event), no product quality complaint reported.Upon internal review, the event device ineffective was determined to be serious due to required intervention (devices).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
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 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 or Problem Description
Jada failed and had to escalate to uae [device ineffective] it was reported that the provider did not think it was a jada error but she thinks it was a user error and thinks she should have pumped up the suction to 90 mm hg instead of 80mm hg.[device use issue] , no additional ae reported, no pqc reported [no adverse event].Case narrative: this initial spontaneous report originating from the united states, was received from clinical educator (ce) on behalf of physician referring to female patient of unknown age.The patient's medical history, drug reactions or allergies, current conditions and concomitant medications were 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 vaginal route (defaulted) (lot #, serial # and expiration date were not reported) for an unknown indication.Ce stated that provider sent her a case study document in which vacuum-induced hemorrhage control system (jada system) failed (device ineffective) and had to escalate to uterine artery embolization (uae).The physician did not think it was a vacuum-induced hemorrhage control system (jada system) error, but she thought it was a user error and thought she should have pumped up the suction to 90 millimeters of mercury (mmhg) instead of 80mmhg (device use issue).She stated moving forward she would have trouble shoot a little better.The vacuum-induced hemorrhage control system (jada system) was left in the entire time.No additional adverse event reported (no adverse event), no product quality complaint reported.Upon internal review, the event device ineffective was determined to be serious due to required intervention (devices).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.Follow up information was received from the physician on (b)(6) 2025.The patient was placed with vacuum-induced hemorrhage control system (jada system) on (b)(6) 2023 (previously was not reported).Onset date of events device ineffective and device use issue was updated as 24-aug-2023.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.

• 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: 22044072
• Report Number: 3002806821-2025-00061
• Device Sequence Number: 9017662
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

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
• 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
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 05/21/2025
• 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: Required Intervention
• Patient Sex: Female