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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/01/2022

Event Type  Injury  

Event Description

She used a jada system on a patient and it "did not work/nurse could not get the wall suction to go below 200 millimeters of mercury (mmhg) [device ineffective].Case narrative: this initial spontaneous report originating from the united states, was received from a physician (reported as provider) via clinical account specialist (cas) referring to a non-pregnant female patient of an unknown age.The patient's concurrent conditions included freakishly large lower uterine segment arteries and hospitalization.Patient's historical conditions included singleton pregnancy, vaginal delivery.Gravida 1 and nulliparous (reported as para 0, discrepant information).Her concomitant medications and drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.On an unknown date in (b)(6) 2022 (reported as one day "last week"), the patient was started on vacuum-induced hemorrhage control system (jada system) green carton (lot# and expiry date were not reported) via vaginal route for hemorrhaging post vaginal delivery (postpartum haemorrhage).The provider reported that one day "last week" (exact date was unknown) she used a vacuum-induced hemorrhage control system (jada system) on a patient and it "did not work", the nurse could not get the wall suction to go below 200 millimeters of mercury (mmhg) and turned the suction on and off several times in an attempt to get it to work, the nurse replaced the wall suction regulator with a different regulator and the suction still would not go below 200 (mmhg) (device ineffective).(provider reported this was a patient that was pregnant for the first time who delivered vaginally and had post-delivery hemorrhaging).The cas asked the provider if the uterus was contracting when the vacuum-induced hemorrhage control system (jada system) was attached to the suction and provider reported she could not tell, provider also used ultrasound but could not see anything.Provider reported the vacuum-induced hemorrhage control system (jada system) was then discontinued, removed, and patient was taken to interventional radiology.The patient sought medical attention and treatment was given.Provider reported she discovered the patient had, "freakishly large lower uterine segment arteries" and stated, "there was no chance the vacuum-induced hemorrhage control system (jada system) would have controlled the bleeding." cas did not know what procedure/interventions were done in interventional radiology, only that the patient was now recovered.No other adverse event (ae) and product quality complaint (pqc) were reported.No additional patient or device information was provided by the nurse.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.Upon internal review, the events device ineffective was determined to be serious as an intervention was required.Medical device reporting criteria: serious injury.

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.

• Brand Name: JADA SYSTEM
• Type of Device: 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, NJ 07302
• MDR Report Key: 16160374
• MDR Text Key: 307318679
• Report Number: 3002806821-2023-00003
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510K K201199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female