MAUDE Adverse Event Report: 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  

Event Description

It initially drained 300 ml of blood, but did not control the bleeding/ device was not working [device ineffective].Case narrative: this spontaneous report originating from the united states was received from a physician via clinical account specialist (cas), referring to a non-pregnant female patient of unknown age.The patient's historical conditions were considered as pregnancy and delivery.Her current conditions included hospitalization and uterine artery bleeding.Her concomitant medications and past drugs/ allergies were not reported.This report concerned 1 patient and 1 device.On an unknown date, the patient had vacuum-induced hemorrhage control system (jada system) placement via intravaginal route (lot# and expiration date were not reported) for postpartum hemorrhage by the reporting physician.Reportedly, after insertion, the device was connected to the suction, and it initially drained 300 milliliters (ml) of blood but did not control the bleeding and the physician felt device was not working (device ineffective) under ultrasound guidance and removed the vacuum-induced hemorrhage control system (jada system).The physician believed the reason for the bleeding was related to a uterine artery bleed.The patient received several units of blood, exact amount was unknown and spent 2 weeks in the intensive care unit (icu) (considered as hospitalization prolonged).Reportedly, the patient sought medical attention and she did not have any documented prenatal care.Clinical account specialist (cas) does not have any patient or device information.All product quality complaint (pqc) answers were unknown by the reporter.Healthcare professional (hcp) does not wish to be contacted.No product quality complaint (pqc) identified.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.For vacuum-induced hemorrhage control system (jada system) serial number was not provided.Upon internal review, the event of device ineffective was considered as serious due to medically significant.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 Contact: 30 hudson street; jersey city, NJ 07302
• MDR Report Key: 18020266
• MDR Text Key: 326700919
• Report Number: 3002806821-2023-00127
• 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: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Patient Outcome(s): Hospitalization; Other
• Patient Sex: Female