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 Hemorrhage/Bleeding (1888); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  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.

Event Description

Staff could never achieve adequate suction and the jada was removed.Patient ended up getting a hysterectomy for continued bleeding [device issue] reporter states they initially put air in the cervical seal and then removed it and put a sterile fluid [wrong technique in device usage process] case narrative: this initial spontaneous report originating from the united states, was received from a physician via company representative, referring to a non-pregnant female patient of an unknown age.The patient's medical history included pregnancy and delivery, and her concurrent conditions included hospitalization.Her past drugs, allergies and concomitant medications were not reported.This report concerns 1 patient and 1 device.On an unknown date, the patient had vacuum-induced hemorrhage control system (jada system) inserted (lot#, serial # and expiration date were not reported) via vaginal route for postpartum hemorrhage by the physician.The reporter stated that there was some trouble achieving suction, because the wall suction nearest the patient was not functional and they had to add 6 feet (ft) additional suction tubing to what was provided with the vacuum-induced hemorrhage control system (jada system).Reporter stated that they initially put air in the cervical seal and then removed it and put a sterile fluid (wrong technique in device usage process).Reporter also stated that they were concerned that possibly the vacuum-induced hemorrhage control system (jada system) was not placed correctly but was on top of the cervix and that was affecting its functioning.Staff could never achieve adequate suction and the vacuum-induced hemorrhage control system (jada system) was removed.Patient ended up getting a hysterectomy for continued bleeding (device issue).Staff reported that while the vacuum-induced hemorrhage control system (jada system) was inserted the uterus was toned, once it was removed it was boggy again.The patient sought medical attention, and the reporter also stated that they believed the lack of suction nearest the patient might have been a factor.No further information was known at the time of reporting.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.Upon internal review, the event of device issue was determined to be serious as it required intervention.Medical device reporting criteria: serious injury.(b)(4).

• 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: 16005568
• MDR Text Key: 305718920
• Report Number: 3002806821-2022-00024
• 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: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• 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