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 Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/09/2012

Event Type  Injury  

Event Description

Nurse states patient experiencing postpartum bleeding and has jada in place and the suction is set to 90 mmhg and the patient is still bleeding [device ineffective].Case narrative: this initial spontaneous report originating from the united states, was received from a nurse, referring to a non-pregnant female patient of unknown age.The patient's concurrent conditions included large uterine fibroid and hospitalization.Patient's historical conditions included pregnancy and delivery.It was reported that the patient had one term pregnancy and post-partum hemorrhage with that birth.Patient received an oxytocin (pitocin) bolus after delivery.Her concomitant medications, and drug reactions/allergies 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# and expiry date were not reported) via vaginal route for postpartum haemorrhage.The nurse who was taking care of the patient stated that, the patient was experiencing postpartum bleeding and had vacuum-induced hemorrhage control system (jada system) in place and the suction was set to 90 millimeters of mercury (mmhg) and the patient was still bleeding at the time of the initial report (device ineffective, onset date: (b)(6) 2022).She urgently wanted to speak to the medical liaison for vacuum-induced hemorrhage control system (jada system).It was also reported that patient had sought medical attention.The nurse also stated that the physician was operating the device however it was her and other nurses who were offering instructions utilizing their "badge buddy" they received from a recent training, and it went very well.The patient had lost 120 milliliter (ml) of blood and the vacuum-induced hemorrhage control system (jada system) was discontinued after 3 hours after controlling the bleeding well (conflicting information).The device was not removed and reinserted.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 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): unexpected medical intervention (b)(4) patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan.

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: 16004509
• MDR Text Key: 305710917
• Report Number: 3002806821-2022-00023
• 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
• Reporter Occupation: Other
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• 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): Other
• Patient Sex: Female