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 09/01/2023

Event Type  Injury  

Event Description

Dic was diagnosed after jada use [disseminated intravascular coagulation] hcp placed jada and the patient¿s bleeding stopped briefly, but the jada canister ¿filled up immediately and ended up performing a hysterectomy and patient received blood products device ineffective.Case narrative: this spontaneous report originating from the united states was received from a clinical nurse educator via company representative, referring to a female patient of unknown age.The patient's historical conditions included: on an unknown date the patient became pregnant and gave birth in (b)(6) 2023 via cesarean section.The patient's current conditions included lower segment uterine atony.The patient's concomitant medications and past drugs/ allergies were not reported.The patient proceeded to lose 1100 milliliter (ml) of blood prior to vacuum-induced hemorrhage control system (jada system) insertion (discrepant information: also reported as 100 milliliter (ml)).This report concerned 1 patient and 1 device.In late (b)(6) 2023, the patient had vacuum-induced hemorrhage control system (jada system) insertion via intrauterine route (lot# and expiration date were not reported) for postpartum hemorrhage by the attending physician.Reportedly, it was physician's first time operating the device.The patient's bleeding was stopped briefly, but the vacuum-induced hemorrhage control system (jada system) canister filled up immediately/ the vacuum-induced hemorrhage control system (jada system) did not stop controlling the bleeding (device ineffective) and worked without device issue.The physician performed a hysterectomy as an escalating treatment which was required after vacuum-induced hemorrhage control system (jada system) use to control the abnormal postpartum uterine bleeding or hemorrhage.It was also reported that the disseminated intravascular coagulation (dic) was diagnosed after vacuum-induced hemorrhage control system (jada system) placement, however, the suspected cause of post-partum hemorrhage was reported as disseminated intravascular coagulation (dic) and uterine atony.The patient received unspecified blood products.The device was not removed and nor reinserted for any reason.No additional adverse event (ae) identified.No product quality complaint (pqc) identified.No additional information was available.It was reported that the patient did not die.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 was not available.The outcome of disseminated intravascular coagulation was unknown.The reporter's causality assessment between the disseminated intravascular coagulation and suspect vacuum-induced hemorrhage control system (jada system) was unknown.Upon internal review, the event of device ineffective was considered as serious due to required intervention and the event disseminated intravascular coagulation and device ineffective were determined to be 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 (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: 17966825
• MDR Text Key: 326067987
• Report Number: 3002806821-2023-00125
• 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: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• 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): Other; Required Intervention
• Patient Sex: Female