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 Date 10/11/2023

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

Patient continued to bleed around the seal [device ineffective] case narrative: this spontaneous report originating from the united states was received from an unspecified consumer via clinical account specialist (cas), referring to a non-pregnant female patient of unknown age.The patient's historical conditions included a "full-term twin pregnancy" which was delivered via cesarean section (c-section).Her gravidity was unknown, but this was patient's first living delivery (considered as primiparous).Her current condition also included hospitalization.Her past drugs/ allergies and concomitant medications were not reported.This report concerns 1 patient and 1 device.On (b)(6) 2023, the patient was placed with vacuum-induced hemorrhage control system (jada system) via intrauterine route by the attending physician for postpartum bleeding, however, the patient continued to bleed around the seal (device ineffective).The device was removed and a new, second vacuum-induced hemorrhage control system (jada system) was placed (refer case # us-organon-(b)(4)), and a hysterectomy was performed.Total estimated blood loss was 3,300 ml.Patient also received blood products (further unspecified).Approximately on an unknown date in 2023, the hospitalization was prolonged due to the event.No further information was provided.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not provided.Upon internal review, the event of device ineffective was considered to be serious due to the required intervention.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.This was one of the two reports received from the same reporter regarding the same patient.

• 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: 17939492
• MDR Text Key: 325733298
• Report Number: 3002806821-2023-00123
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/16/2023

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: 10/16/2023
• 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