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 Hemorrhage/Bleeding (1888)

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

Jada partially expelled [device expulsion].Patient continued to bleed around the device [device ineffective].Vomiting [vomiting].Cervical seal was then filled to a total of 180 ml [wrong technique in device usage process].Case narrative: this initial spontaneous report originating from the united states, was received from a nurse via clinical account specialist (cas) referring to a non-pregnant female patient of an unknown age.It was reported that patient of unknown gestation delivered vaginally and experienced postpartum hemorrhage, cause of which was suspected to be uterine atony.Her concomitant medication included oxytocin citrate (pitocin), methergine, misoprostol (cytotec), and tranexamic acid.Her drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.On an unknown date (reported as couple of weeks ago) the patient was started on vacuum-induced hemorrhage control system (jada system) (lot# and expiry date were not reported) via intrauterine route for postpartum hemorrhage and cervical seal was filled with 120 milliliters (ml).However, patient continued to bleed around the device (device ineffective) and patient began vomiting and vacuum-induced hemorrhage control system (jada system) partially expelled (device expulsion).No further details were provided on expulsion.Vacuum-induced hemorrhage control system (jada system) was repositioned, cervical seal was then filled to a total of 180 ml (wrong technique in device usage process) and it worked successfully.Vacuum-induced hemorrhage control system (jada system) was used a total of 3 hours.Total blood loss was unknown as it did not reach the canister, only reached "1/3 of the way up the tubing" prior to resolution of postpartum hemorrhage.No other adverse event (ae) and product quality complaints (pqc) were reported.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.The outcome of vomiting was not provided.Upon internal review, the event device expulsion and device ineffective were 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).

• 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: 16305135
• MDR Text Key: 308864084
• Report Number: 3002806821-2023-00006
• 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
• Type of Report: Initial
• Report Date: 02/02/2023

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
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2023
• 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
• Treatment: CYTOTEC (MISOPROSTOL),; METHERGINE (METHYLERGOMETRINE MALEATE),; PITOCIN [OXYTOCIN CITRATE] (OXYTOCIN CITRATE),; TRANEXAMIC ACID (TRANEXAMIC ACID),
• Patient Outcome(s): Other
• Patient Sex: Female