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); Insufficient Information (4580)

Event Date 04/17/2024

Event Type  Injury  

Event Description

Did the jada device stop control the bleeding? no [device ineffective] no additional ae reported [no adverse event].Case narrative: this spontaneous report originating from united states was received from other via clinical account specialist (cas) referring to a female patient of unknown age.The patient¿s historical condition included pregnancy and delivery.The patient's historical drugs included oxytocin (oxycotin), misoprostol, tranexamic acid (txa) and carboprost trometamol (hemabate).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 17-apr-2024, the patient was placed with vacuum-induced hemorrhage control system (jada system) (lot #, serial # and expiration date were not reported) (during the night shift) via vaginal route for post-partum hemorrhage.Vacuum-induced hemorrhage control system (jada system) was placed somewhere at a greater than 3,000 milliliter blood loss and it did not stop bleeding (device ineffective).It was reported that the patient had all the medications and received blood products.The patient sought medical attention.No additional adverse event (ae) reported (no adverse event), no product quality complaint (pqc) reported.Patient was in hospital when the vacuum-induced hemorrhage control system (jada system) was placed.On 18-apr-2024, therapy with vacuum-induced hemorrhage control system (jada system) was withdrawn.Upon internal review, the event device ineffective was determined to be serious due to required intervention (devices).This case was linked to same patient linked cases included, first vacuum-induced hemorrhage control system (jada system) was placed somewhere at a greater than 3,000ml blood loss (device ineffective) (reported in oars # (b)(4) and a different nurse mentioned to the cas that a second vacuum-induced hemorrhage control system (jada system) was placed/ patient did have a hysterectomy and was currently in the intensive care unit (icu) not doing well (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: 19173323
• MDR Text Key: 340934323
• Report Number: 3002806821-2024-00037
• 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: Other,Company Representative
• Reporter Occupation: Other
• 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?: Yes
• Device Operator: Health Professional
• 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