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)
Date of Event	04/25/2025
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
A 2nd jada was placed by hcp.Patient was moved to the icu.Jada system did not work [device ineffective].The device was not inserted correctly [device use error].Case narrative: this spontaneous report originating from united states was received from a physician, referring to a female patient of unknown age, via territory manager (tm).The patient's concomitant medications and past drug reactions/allergies were not reported.The patient's current condition was gravida 3.On (b)(6) 2025, the patient presented to the hospital (hospitalized) in active labor and delivered quickly.20 minutes later delivery, the patient experienced postpartum hemorrhage (pph) and was moved to the obstetrician (ob) floor.The tm stated the nurse told her that all of the medications to stop the pph were administered unsuccessfully.It was believed the patient had an estimated blood loss (ebl) of 2000.Then the vacuum-induced hemorrhage control system (jada system) was inserted by physician, and it worked for 1 to 2 hours before the patient started bleeding again.Patient was taken to the operating room (or) where jada system was removed and a dilatation and curettage (d&c) performed.This report concerns 1 patient(s) and 1 device(s).On (b)(6) 2025, the patient was placed with second vacuum-induced hemorrhage control system (jada system) 2.0 via intravaginal route (lot #, serial # and expiration date was not reported) for postpartum hemorrhage by physician.Patient was moved to the intensive care unit (icu).The second vacuum-induced hemorrhage control system (jada system) did not work (device ineffective), patient was taken back to the operation room (or) where a hysterectomy was performed.The patient received blood products (unknown products) and her ebl was 7l.During the 2nd insertion of vacuum-induced hemorrhage control system (jada system), the nurse felt the physician did not insert the device correctly.The tm also stated the training status of both physicians who had placed both vacuum-induced hemorrhage control system (jada system) was unknown.She felt strongly that both the vacuum-induced hemorrhage control system (jada system) was not inserted correctly and felt that this was user error on both physician's part (device use error).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.This case was linked to same patient linked case included, patient was placed with first vacuum-induced hemorrhage control system (jada system), it worked for 1 to 2 hours before the patient started bleeding again, she was taken to the operation room and a dilation and curettage (d&c) performed (reported in (b)(4)).

• 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: 21983736
• Report Number: 3002806821-2025-00060
• Device Sequence Number: 19911465
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/08/2025
• 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; Hospitalization
• Patient Sex: Female