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 Code	Hemorrhage/Blood Loss/Bleeding (1888)
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
2nd jada system was placed and worked as it should.Patient was taken to interventional radiology for unknown procedure where bleeding was stopped and jada was removed.[device ineffective].Case narrative: this spontaneous report originating from united states was received from a nurse referring to a female patient of an unknown age via clinical account specialist (cas).The patient came into the hospital in active labor, gestation unknown, gravida (g5), parity 4 (p4), with a history of 4 previous postpartum hemorrhages.The patient given a live birth in the past with history of abnormal postpartum uterine bleeding or hemorrhage.The patient delivered vaginally by midwife and after delivery patient experience uterine atony.The patient's current pregnancy type was singleton.The patient past drugs/allergies, concomitant medications were not reported.This report concerns 1 patient(s) and 1 device(s).On an unknown date, the vacuum-induced hemorrhage control system (jada system) was placed, left in place for 90 minutes connected to suction.The suction was turned off and device was left in place for 30 minutes with no further bleeding, device was removed.The bleeding was continued or re-started during the vacuum-induced hemorrhage control system (jada system) verification step (several hours later patient experienced return of bleeding) and the 2nd vacuum-induced hemorrhage control system (jada system) 2002, was placed via intravaginal route (lot #, serial # and expiration date were not reported) for postpartum hemorrhage and worked as it should.The patient was taken to interventional radiology for unknown procedure where bleeding was stopped and vacuum-induced hemorrhage control system (jada system) was removed (device ineffective).Hospitalization was prolonged due to this event.Total ebl (estimated blood total) was 5l, patient received several units of rbc's (red blood cells), number was unknown.The operator was not using vacuum-induced hemorrhage control system (jada system) for the first time.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.

• 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: 21880430
• Report Number: 3002806821-2025-00056
• Device Sequence Number: 8640898
• 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
• Report Date (Section B): 04/22/2025

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
• Initial Report FDA Received Date: 04/22/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Female