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 04/20/2023

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].Case narrative: this spontaneous report originating from united states was received from a physician via clinical educator referring to a non-pregnant female patient of unknown age.The patient's medical history included pregnancy and had delivery.The patient's concurrent conditions included pph (postpartum haemorrhage), her concomitant medications, and past drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.On (b)(6) 2023, the patient was inserted with vacuum-induced hemorrhage control system (jada system), intravaginally by attending physician for postpartum hemorrhage (postpartum haemorrhage).On the same day, the patient was admitted to intensive care unit (icu) for hemorrhage and disseminated intravascular coagulation (dic) (discrepancy: dic was also reported as medical history and suspected cause of pph).The vacuum-induced hemorrhage control system (jada system) was started late and did control the bleeding.The vacuum-induced hemorrhage control system (jada system) left in place for 24 hours.Clinical educator was asked should antibiotics be initiated, and provider was directed to pearl study information.Patient was given blood transfusions/blood products during peripartum.The patient sought medical attention and she did not die.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.Therapy with vacuum-induced hemorrhage control system (jada system) was discontinued on (b)(6) 2023.The outcome of disseminated intravascular coagulation was considered as not recovered (reported as "patient was in dic").The reporter's causality assessment was not provided.Upon internal review, the event of disseminated intravascular coagulation was 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.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): 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: 16901831
• MDR Text Key: 314902532
• Report Number: 3002806821-2023-00050
• 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: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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