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); Insufficient Information (4580)

Event Date 08/13/2023

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

At some point she did go into dic [disseminated intravascular coagulation] bleeding continued around the seal [device ineffective] case narrative: this spontaneous report originating from united states was received from a nurse manager via clinical account specialist (cas), referring to a female patient of unknown age.The patient's medical history included pregnancy and delivery.Her current conditions, past drugs/allergies and concomitant therapy were not provided.This report concerns 1 patient and 1 device.It was reported that the patient delivered at a different facility and was brought to the reporter's hospital by ambulance through the emergency room (er).The provider and a nurse from obstetrics (ob) went to the er to take care of the patient.It was reported that the patient lost a lot of blood before arriving in the er.On (b)(6) 2023, the vacuum-induced hemorrhage control system (jada system) was placed via vaginal route by the attending physician for the postpartum hemorrhage, but the bleeding continued around the seal (device ineffective).On the same day, the vacuum-induced hemorrhage control system (jada system) was removed.Ultimately the provider had to take the patient to the operating room (or), and she ended up having a hysterectomy (also reported as treatment).At some point she did go into disseminated intravascular coagulation (dic) (onset date: (b)(6) 2023) (also reported as "diagnosed after placement of device") and they thought maybe that was why the bleeding did not stop with the vacuum-induced hemorrhage control system (jada system).Reportedly, the patient was transferred again (facility unknown) and has been in the hospital since (b)(6) 2023, was in the intensive care unit (icu) (hospitalization) and was currently on dialysis (considered as treatment and medical intervention).It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.For vacuum-induced hemorrhage control system (jada system), the lot number and the serial number were not available.At the time of reporting, the outcome of disseminated intravascular coagulation was considered as not recovered.The causality assessment was not reported.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 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 fda code: (health effects - health impact per annex f): 4624 surgical intervention (one or more surgical procedures was required, or an existing procedure changed).Fda code: (health effects - health impact per annex f): 4641 unexpected medical intervention (patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan).Fda code: (health effects - health impact per annex f): 4607 hospitalization or prolonged hospitalization (hospitalization or prolonged hospitalization due to the health damage accompanying the use of device).Fda code: (health effects - health impact per annex f): 4608 intensive care (patient requires admission to or extension of stay in an intensive care unit.).

• 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: 17797560
• MDR Text Key: 324012144
• Report Number: 3002806821-2023-00113
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/22/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2023
• 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; Other
• Patient Sex: Female