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

Lot Number UNKNOWN

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

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

Patient continued to bleed around the cervical seal [device ineffective].No additional adverse event (ae) reported [no adverse event].Case narrative: this spontaneous report was received from a nurse via clinical account specialist (cas) referring to a female (conservatively) patient of unknown age and gender.The patient's current condition, historical condition, concomitant medications and past drug reactions/allergies were not reported.This report concerns 1 patient(s) and 1 device(s).On unknown date, the patient underwent insertion with vacuum-induced hemorrhage control system (jada system) (route, lot #, serial # and expiration date were not reported) for postpartum hemorrhage.On an unknown date, clinical account specialist reported that vacuum-induced hemorrhage control system (jada system) was placed for postpartum hemorrhage and bleeding was not contained.Patient continued to bleed around the cervical seal.Uterine artery embolization performed.Patient required intensive care unit admission and had since recovered and been discharged.No additional adverse event (ae) reported (no adverse event).No additional details known.Therapy with vacuum-induced hemorrhage control system (jada system) was unknown.Upon internal review, the event of device ineffective was considered as serious due to the 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.Fda code: (health effects - health impact per annex f): 4608 intensive care (patient requires admission to or extension of stay in an intensive care unit.) 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: 18666777
• MDR Text Key: 334839932
• Report Number: 3002806821-2024-00004
• 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: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: UNKNOWN
• 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