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); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

First jada system fell out when patient moved during two resuscitations [device expulsion].No additional ae provided [no adverse event].Case narrative: this spontaneous report originating from united states was received from a nurse via regional manager, referring to a non-pregnant female patient of unknown age.The patient's medical history included singleton fetal demise.The patient¿s current condition, concomitant medications and past drug reactions/allergies were not reported.This report concerns 1 patient(s) and 1 device(s).On unknown date, the patient was placed with vacuum-induced hemorrhage control system (jada system) (lot #, serial # and expiration date were not reported) via intrauterine route for postpartum hemorrhage.On an unknown date, first vacuum-induced hemorrhage control system (jada system) fell out when patient moved during two resuscitations (device expulsion).Another vacuum-induced hemorrhage control system (jada system) was used but hemorrhage continued.Bakri uterine balloon was initiated, and patient was transferred to another hospital.The second vacuum-induced hemorrhage control system (jada system) worked without issue, but the bleeding continued.After initial bleeding control by vacuum-induced hemorrhage control system (jada system), there was another bleeding episode.The patient sought medical attention.No product quality complaint (pqc) reported.No additional adverse event (ae) (no adverse event) or information provided.Therapy with vacuum-induced hemorrhage control system (jada system) was withdrawn on an unknown date.The outcome of device expulsion was unknown.The reporter¿s causality assessment was not provided.Upon internal review, the event device expulsion was determined to be serious due required intervention (devices).This case was linked to same patient linked cases included (first vacuum-induced (jada system) fell out when patient moved during two resuscitations) (device expulsion) (reported in oars # (b)(4)).Vacuum-induced (jada system) was used but hemorrhage continued (device ineffective) (reported in oars # (b)(4)).When the lot number is unknown, a technical investigation of the specific manufacturing process which includes review of records associated with a known lot number cannot be performed.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: 19174490
• MDR Text Key: 340948554
• Report Number: 3002806821-2024-00038
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/24/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female