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

Patient continued to bleed with jada system in place [device ineffective] case narrative: this spontaneous report originating from the united states was received from a physician via clinical sales representative (cse), referring to a female patient of unknown age.The patient's historical conditions included singleton pregnancy, and delivery.She was g1p1 (gravida 1 and para 1), and her current conditions also included uterine atony and perineal laceration.Her concomitant medication included methylergometrine maleate (methergine).The estimated blood loss (ebl/qbl) prior to vacuum-induced hemorrhage control system (jada system) use was 600-800 ml (reported as liter; discrepancy).Her past drugs/ allergies were not reported.This report concerned 1 patient and 1 device.On an unknown date, the patient was placed with vacuum-induced hemorrhage control system (jada system) via vaginal route for postpartum hemorrhage, however, the patient continued to bleed with the device in place (device ineffective) 600-800 ml of blood was collected in the vacuum-induced hemorrhage control system (jada system) canister.The device was removed on the same day, and the patient was taken interventional radiology for a hysterectomy.Reportedly, the patient sought medical attention.More than one device was not used.The device was not removed and then reinserted for any reason.Estimated total blood loss at delivery was 1.8 liter.The suspected cause of postpartum hemorrhage was uterine atony.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 determined to be serious due to 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.

• 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: 17981455
• MDR Text Key: 326240289
• Report Number: 3002806821-2023-00126
• 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: Physician
• Type of Report: Initial
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• 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
• Treatment: METHERGINE (METHYLERGOMETRINE MALEATE),
• Patient Outcome(s): Required Intervention
• Patient Sex: Female