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 Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/15/2022

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

But did not work properly [device ineffective].As the blood kept clotting behind the device [device occlusion].Case narrative: the spontaneous report was received from a nurse via field-based employee referring to non-pregnant female patient of unknown age.The patient historical condition included anemia with no history of post-partum hemorrhage, scheduled cesarean section (c-section) with spinal, gravida 2 and para 1 (g2 p1) with a singleton pregnancy.The patient¿s concurrent condition included hospitalization.The patient¿s concomitant medication included oxytocin (reported as oxytocin bolus) and methylergometrine maleate (methergine).The patient¿s historical medications, and past drug reactions/allergies were not reported.This report concerned 1 patient and 2 devices.On (b)(6) 2022 (also reported late yesterday afternoon), the patient was inserted with vacuum-induced hemorrhage control system (jada system 1 and 2) via intravaginal route (lot# and expiration date was not reported) for an unknown indication.It was reported patient gestation period was unknown and was no invasive placenta.Patient uterus was ¿swept¿ prior to incision closed.The reporter stated, patient noticed 2 devices were placed separately after a c-section (cesarean section) but did not work properly (drug ineffective) as the blood kept clotting behind the device (device occlusion).The patient was hospitalized due the events.Two vacuum-induced hemorrhage control system (jada system 1 and 2) were utilized and neither device controlled the bleeding due to blood clotting behind the device and the patient underwent a full hysterectomy.The patient required maternal admission to intensive care unit (icu) overnight until patient was hemodynamically stable due to which blood products were required however, blood type and volume were unknown.The reporter had no other details at this time and stated she had reached out to the nurse educator and had not heard back.It was reported the patient was not died.The patient sought for medical attention.No product quality compliant (pqc) were reported.Upon internal review, the events drug ineffective and device occlusion were considered to be serious as it required surgical intervention.Medical device reporting criteria: serious injury.(b)(4).

• 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: 16077514
• MDR Text Key: 306420995
• Report Number: 3002806821-2022-00037
• 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: 12/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: METHERGINE (METHYLERGOMETRINE MALEATE),; OXYTOCIN (OXYTOCIN),
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female