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 Disseminated Intravascular Coagulation (DIC) (1813); Hemorrhage/Bleeding (1888)

Event Date 05/31/2023

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

Dic [disseminated intravascular coagulation].The jada system was placed and connected to suction, and blood was immediately visualized.800 ml of blood was collected in the canister "within minutes", leading to device removal [device ineffective].Case narrative: this spontaneous report originating from united states was received from a nurse (also reported as facility) via clinical educator, referring to a 28-year-old female patient.This report concerns 1 patient and 1 device.The patient was g2p1 (gravida 2 and para 1) and had a history of previous twin delivery via caesarean-section due to spontaneous breach of twin a.On (b)(6) 2023, the patient was presented for a non-scheduled vaginal delivery of a singleton pregnancy at 41 weeks gestation.She pushed for 6 hours and was diagnosed with failure to descend and chorioamnionitis.She was then taken for cesarean delivery, and lost 2000 ml of blood.The methylergometrine maleate (methergine) was given intramuscularly (im) twice, tranexamic acid (txa) was given twice, misoprostol (cytotec) was given once via rectum, and intramyometrial injection (intramuscular) of vasopressin was given twice prior to vacuum-induced hemorrhage control system (jada system) insertion.On (b)(6) 2023, the patient was inserted with vacuum-induced hemorrhage control system (jada system) via vaginal route for postpartum hemorrhage by the attending physician (reported as "attending").Reportedly, the device came with a blue seal valve.It was connected to suction, and blood was immediately visualized.800 ml of blood was collected in the canister "within minutes", leading to device removal (device ineffective), as patient was then diagnosed with disseminated intravascular coagulation (dic).The patient was taken for an ovarian sparing hysterectomy.Total blood loss was 9750 ml.Patient received 25 units (discrepancy; also reported as 23 units) of red blood cells and 3 units of platelets.Uterine pathology showed no evidence of uterine window or placenta accreta.Patient recovered and discharged with baby.It was unknown if patient required intensive care unit (icu) admission.The suspected cause of the postpartum hemorrhage was coagulopathy (considered as current condition).It was also reported that the patient sought medical attention.The adverse event (ae) was not cancer, and there was no patient overdose.More than 1 device was not used.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.For vacuum-induced hemorrhage control system (jada system) lot number and serial number were not provided.Upon internal review, the event of disseminated intravascular coagulation was determined to be medically significant, and the events of disseminated intravascular coagulation and device ineffective were considered as 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.Fda code: (health effects - health impact per annex f): 4625 additional surgery (surgical intervention that was not planned and needed to be performed in addition to other interventions including surgical ones).Fda code: (health effects - health impact per annex f): 4643 blood transfusion (patient required an infusion of whole blood or a blood component directly into the bloodstream.).

• 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: 17210178
• MDR Text Key: 317988499
• Report Number: 3002806821-2023-00075
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• 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
• Treatment: CYTOTEC (MISOPROSTOL).; METHERGINE (METHYLERGOMETRINE MALEATE).; TRANEXAMIC ACID (TRANEXAMIC ACID).; VASOPRESSIN (VASOPRESSIN),INJECTION.
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 28 YR
• Patient Sex: Female