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 05/13/2023

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

Jada would not go in [device placement issue].Case narrative: this initial spontaneous report originating from the united states, was received from an unspecified nurse via clinical educator (ce) referring to a female patient of unknown age.The patient's historical conditions included pregnancy and vaginal delivery.The ce reported that patient was given tranexamic acid (reported as txa), methylergometrine maleate (methergine) and misoprostol (cytotec) prior to use of vacuum-induced hemorrhage control system (jada system).The patient's concurrent conditions, concomitant drugs and allergies were not reported.This report concerns 1 patient and 1 device.On (b)(6) 2023, the physician attempted to insert vacuum-induced hemorrhage control system (jada system) via vaginal route (lot #, serial # and expiration date were not reported) for postpartum hemorrhage, however, the vacuum-induced hemorrhage control system (jada system) would not go in (device placement issue).The nurse reported the uterus was rock hard but kept bleeding and stated that there was a speculation that it was a cervical bleed.Reportedly, it was not the physician's first time using the device.The patient had to undergo hysterectomy (also reported as treatment; discrepancy).It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.Upon internal review, the event of device placement issue was considered as serious as it 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).

• 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: 16993693
• MDR Text Key: 315862254
• Report Number: 3002806821-2023-00061
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• 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: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• 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