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

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

Patient Problem Insufficient Information (4580)

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

Did the jada device stop control the bleeding? no [device ineffective] jada system was not inserted correctly and the patient got a bakri successfully placed [wrong technique in device usage process] this initial spontaneous report originating from united states was received from health care professional (hcp) via customer account specialist (cas), referring to a non-pregnant female patient of unknown age.This report concerned 1 patient and 1 device.The patient's concurrent conditions, concomitant medications and drug reactions/allergies were not reported.On an unknown date, the patient became pregnant and had a delivery.On an unknown date, the patient underwent vacuum-induced hemorrhage control system (jada system) insertion via vaginal route (lot#, serial # and expiration date were not reported) for postpartum hemorrhage.It was reported that the vacuum-induced hemorrhage control system (jada system) came with a blue seal valve kit and green carton.The operator of the device was a midwife.Vacuum-induced hemorrhage control system (jada system) was not inserted correctly (wrong technique in device usage process) and the device did not control the bleeding (device ineffective).It was also reported that the vacuum-induced hemorrhage control system (jada system) worked without any issue, but the bleeding continued.Vacuum -induced hemorrhage control system (jada system) was removed and a bakri was successfully placed to control the bleeding.The reporter stated that she did not know the date of occurrence or the cause of the post-partum hemorrhage and had no additional information to provide.No other adverse event (ae) or product quality complaint (pqc) was reported.The availability of vacuum-induced hemorrhage control system (jada system) for evaluation was unknown.Upon internal review, the events device ineffective and wrong technique in device usage process were determined to be serious as a medical intervention was required.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: 15967690
• MDR Text Key: 305340318
• Report Number: 3002806821-2022-00019
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/13/2022

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2022
• 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