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 Type  Injury  

Event Description

Later the patient became hemodynamically unstable and they needed to remove [haemodynamic instability] did the jada device stop control the bleeding? yes, at first [device ineffective] they could see a lot of clots behind it when they removed the jada [device occlusion] case narrative: this initial spontaneous report originating from the united states, was received from a labor and delivery clinical nurse educator via clinical accounts specialist (cas), referring to a female patient of unknown age.The patient's concurrent conditions included uterine atony, multigravida and multiparous (reported as "patient's 3rd or 4th pregnancy with 3 or 4 births").Her historical conditions included pregnancy and caesarean delivery.Her past drugs, concomitant medication and allergies were not reported.This report concerns 1 patient and 1 device.On an unknown date, the physician inserted vacuum-induced hemorrhage control system (jada system) via vaginal route (lot #, serial # and expiration date were not reported) for postpartum hemorrhage.Reportedly, the device came with blue seal valve, kit and green carton.The reason of postpartum hemorrhage was suspected to be uterine atony.The physician got control of the bleeding immediately, but then later the patient became hemodynamically unstable (haemodynamic instability, onset date: unknown), and they needed to remove the vacuum-induced hemorrhage control system (jada system).It was also reported that the vacuum-induced hemorrhage control system (jada system) only controlled the bleeding at first (device ineffective, onset date: unknown), however, there was another bleeding episode.A lot of clots were seen behind it when the vacuum-induced hemorrhage control system (jada system) (device occlusion) was removed.The patient sought medical attention and then she was taken to the operating room and got a hysterectomy (also reported as treatment).It was also reported that the adverse event (ae) was not a cancer or a congenital anomaly.The patient did not die and there was no patient overdose.More than one vacuum-induced hemorrhage control system (jada system) was not used, and the device was not removed and then reinserted again.The attending physician received training on vacuum-induced hemorrhage control system (jada system) usage in january or (b)(6) 2023.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.The outcome of haemodynamic instability was considered to be recovered (reported as the patient "recovered well").The reporter's causality assessment was not reported.Upon internal review, the events of haemodynamic instability, device ineffective and device occlusion were considered as serious as they 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).

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: 17001469
• MDR Text Key: 315914871
• Report Number: 3002806821-2023-00062
• 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: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• 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): Required Intervention
• Patient Sex: Female