MAUDE Adverse Event Report: ORGANON & CO. JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/05/2023

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

Vaginal bleeding was not well controlled and patient was taken to interventional radiology for an uterine artery embolization which was successful [device ineffective].Case narrative: this initial spontaneous report originating from the united states was received from a nurse via clinical sales educator (cse) referring to a non-pregnant female patient of unknown age.The patient had a history of postpartum hemorrhage with previous birth that did not require blood products or an extended length of stay.Nurse denied patient history of hypertension, fibroids, previous caesarean (c)-section, prolonged labor, high dose oxytocin (pitocin), or lacerations.Nurse reported that the patient was gravida 3 and para 2 at 40 weeks and 5 days that was being induced for suspected macrosomia.Nurse reported patient delivered baby and placenta vaginally without complication, immediately breastfeed baby, and was stable for 30 minutes.Pregnancy type was a singleton.The patient was then assisted to a standing position to use the restroom and patient reported not feeling so good.The nurse observed significant vaginal bleeding (no information was known about that statement or amount).She was unsure of the cause of the postpartum hemorrhage.Nurse reported patient was assisted back to bed and received oxytocin (pitocin), misoprostol, tranexamic acid (reported as "txa"), methylergometrine maleate (methergine), and carboprost trometamol (hemabate) prior to use of vacuum-induced hemorrhage control system (jada system).Nurse was unsure of order of medications and timing in relation to the vacuum-induced hemorrhage control system (jada system) being placed.On (b)(6)2023, the attending physician placed vacuum-induced hemorrhage control system (jada system) green carton via vaginal route for postpartum hemorrhage (postpartum haemorrhage).Nurse reported once the vacuum-induced hemorrhage control system (jada system) was placed the patient's fundus was firm, but the vaginal bleeding was not well controlled (device ineffective), and the nurse continued to observe steady flow of blood into the vacuum-induced hemorrhage control system (jada system) canister.They could not get a good seal.She was unable to confirm if the cervical seal was properly inflated and in place but did recall that at the advice of another nurse the provider removed some of the fluid from the cervical seal trying to troubleshoot.The vacuum-induced hemorrhage control system (jada system) was removed on the same day.The patient's care was escalated, and patient was taken to interventional radiology for a uterine artery embolization which was successful.Nurse reported patient was taken to medical intensive care unit (icu) overnight for 1 day and received 2 units of packed red blood cells.The patient sought medical attention.The total blood loss was 2198 milliliter (ml) which included 700ml in the vacuum-induced hemorrhage control system (jada system) canister.Patient was eventually discharged home in stable condition on an unknown date in (b)(6) 2023.The device was not removed and reinserted.There was no congenital anomaly, no cancer, no significant disability or incapacity, no life threatening, no overdose, and the patient 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 was unknown.Upon internal review, the event of device ineffective was 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): 4624 surgical intervention (one or more surgical procedures was required, or an existing procedure changed).Fda code: (health effects - health impact per annex f): 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: 16984928
• MDR Text Key: 315856233
• Report Number: 3002806821-2023-00059
• 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: 05/23/2023

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: 05/23/2023
• 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
• Treatment: HEMABATE (CARBOPROST TROMETAMOL),; METHERGINE (METHYLERGOMETRINE MALEATE),; MISOPROSTOL (MISOPROSTOL),; PITOCIN [OXYTOCIN] (OXYTOCIN),; TRANEXAMIC ACID (TRANEXAMIC ACID),
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female