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 Hemorrhage/Bleeding (1888); Insufficient Information (4580)

Event Type  Injury  

Event Description

Caller reports that a patient experienced postpartum hemorrhage and "bled at least 6 liters".Caller reports that the jada was placed "at some point" but did not control the bleeding.[device ineffective].No additional ae/pqc reported [no adverse event].Case narrative: this spontaneous report originating from united states was received from a other health professional (nurse) via clinical account specialist (cas) referring to a female patient of unknown age.The patient's concurrent condition included postpartum hemorrhage.The patient's historical condition included pregnancy and delivery.The concomitant medications, past drugs and past drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.On an unknown date, the patient was placed with vacuum-induced hemorrhage control system (jada system) via unknown route (lot and expiration date were not reported) for postpartum hemorrhage.On an unknown date, the patient experienced postpartum hemorrhage and bled at least 6 liters.The vacuum-induced hemorrhage control system (jada system) was placed at some point but did not control the bleeding (device ineffective).The patient ended up needing a hysterectomy.Not more than one vacuum-induced hemorrhage control system (jada system) device used.Nurse stated that she had very limited details.No additional adverse event (no adverse event) and product quality complaint reported.Upon internal review, the event device ineffective was considered to be serious due to required intervention (devices).Medical device reporting criteria: serious injury.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.

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: 19151842
• MDR Text Key: 340691411
• Report Number: 3002806821-2024-00032
• 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: 04/22/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/22/2024
• 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