MAUDE Adverse Event Report: ORGANON & CO. JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

Model Number	JADA-1001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
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
This initial spontaneous report originating from the united states, was received from a registered nurse, referring to a female patient of unknown age.The patient's historical condition included caesarean section.The patient's current conditions and concomitant medications were not reported.This report concerns 1 patient and 1 device.On (b)(6) 2022, the patient was started on vacuum-induced hemorrhage control system (jada system) (lot# was not reported) for postpartum hemorrhage (pph).The reporter stated that the vacuum-induced hemorrhage control system (jada system) was difficult to place (device placement issue), because the patient had a caesarean section.The reporter stated that this was the first time they were using the vacuum-induced hemorrhage control system (jada system).The reporter stated that the suction tubing of the vacuum-induced hemorrhage control system (jada system) was filing up with blood up to the canister.They were told by their representative that if this occurred then the vacuum-induced hemorrhage control system (jada system) was not working (device ineffective).They were unclear of the total volume of blood that was in the tubing but through trial and error they believed that the blood within the tubing was 60 milliliters (ml) at the time of the call.The bleeding had not stopped during the call and the uterus was firm.They stated that the suction was working, and that placement was correct using an ultrasound.The nurse also stated they were curious if there was a blood clot and that they could set the pressure to 80 but it kept going up to 95 (wrong technique in device usage process).The patient was under treatment at the time of the call and all the assistance provided during the call did not help.Hence, the case was escalated as they were needing immediate assistance (required intervention).No further details known or available at the time of report.The availability of the vacuum-induced hemorrhage control system (jada system) for evaluation was unknown.Upon internal review, the event of "device ineffective" was determined to be medically significant.Medical device reporting criteria: serious injury.Fda code: health effects - health impact (per annex f): 4648 insufficient information (there is not yet enough information available to classify the health impact.) fda code: (health effects - health impact per annex f): 4641 (unexpected medical intervention) patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan.

• Brand Name: JADA SYSTEM
• Common Device Name: INTRAUTERINE VACUUM CONTRACTION SYSTEM
• Manufacturer (Section D): ORGANON & CO.; 30 hudson street, jersey city; NJ 07302
• Manufacturer (Section G): ORGANON & CO.; 30 hudson street, jersey city; NJ 07302
• Manufacturer Contact: 30 hudson street, jersey city
• MDR Report Key: 15988489
• Report Number: 3017425145-2022-00149
• Device Sequence Number: 5672626
• Product Code: OQY
• UDI-Device Identifier: 00850017882003
• UDI-Public: (01)00850017882003
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K201199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/15/2022

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
• Device Model Number: JADA-1001
• Device Catalogue Number: JADA-1001
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 12/15/2022
• 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; Required Intervention
• Patient Sex: Female