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 10/09/2023

Event Type  Injury  

Event Description

Jada was not adequately controlling the bleeding [device ineffective].Case narrative: this spontaneous report originating from united states was received from a registered nurse (unit charge nurse) via clinical educational specialist (ces), referring to a female patient of unknown age.The patient's medical history included: on an unknown date, the patient singleton pregnancy and was hospitalized (current condition) in (b)(6) 2023 for labor induction at term (reported as gestational age) through cesarean section (non-scheduled) due to failure to progress for normal delivery.On (b)(6) 2023, the patient had cesarean section.The patient's concurrent conditions included obesity, prediabetes, pre-eclampsia.The patient was nulliparous (p0) with gravida i (g1).The patient's concomitant therapy included carboprost trometamol (hemabate) prior to vacuum-induced hemorrhage control system (jada system) insertion (with no details provided).It was reported that the patient was out of the operating room (or) and post anesthetic care unit (pacu) and was recovering in the postpartum unit.This report concerned 1 patient and 1 device.On (b)(6) 2023, the patient had vacuum-induced hemorrhage control system (jada system) insertion via intrauterine route (lot# and expiration date were not provided) for post-partum hemorrhage.It was reported that the device was inserted and connected to suction with an unknown section level and 400 milliliter (ml) blood was collected in the canister.It was reported that the time frame from connection of suction to return and accumulation of 400 ml was unknown.The provider determined due to the 400ml of blood in the canister, the vacuum-induced hemorrhage control system (jada system) was not adequately controlling the bleeding (device ineffective) and required prolongation of hospitalization and removed the vacuum-induced hemorrhage control system (jada system) on (b)(6) 2023.The provider then inserted an intrauterine tamponade device as an escalating treatment after vacuum-induced hemorrhage control system (jada system) use to control the abnormal postpartum bleeding and it controlled bleeding (required intervention).It was reported that the patient recovering from the state and was not sure whether there was adequate time to assess vacuum-induced hemorrhage control system (jada system) function.The patient sought medical attention.It was reported that no ultrasound used at any point to evaluate during vacuum-induced hemorrhage control system (jada system) use and one device was only used.No further adverse event (ae) reported, no product quality complaint (pqc reported, no additional details or information was known or available on the event.The reporter does not have the name or contact information for the provider at this time but agrees to contact.For vacuum-induced hemorrhage control system (jada system), the lot number and the serial number was not available.Upon internal review, the event of device ineffective was considered to be medically significant, required intervention and hospitalization prolongation.Medical device reporting criteria: serious injury.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.

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: 17938458
• MDR Text Key: 325682035
• Report Number: 3002806821-2023-00121
• 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: Other
• Type of Report: Initial
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: 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: HEMABATE (CARBOPROST TROMETAMOL),
• Patient Outcome(s): Required Intervention; Hospitalization; Other
• Patient Sex: Female