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 Insufficient Information (4580)

Event Date 02/01/2023

Event Type  Injury  

Event Description

After 30 minutes of use there was a clot in the suction tubing and the provider removed the jada system and found clots in the intrauterine loop as well that were compromising the suction of the jada system [device occlusion].Compromising the suction of the jada system, the provider then placed a second vacuum-induced hemorrhage control system (jada system) [device ineffective].Case narrative: this initial spontaneous report originating from the united states was received from a nurse via field representative, referring to a female patient of unknown age.The patient¿s concurrent conditions, concomitant medications, medical history, and past drug reactions/allergies were not reported.This report concerns 1 patient and 2 devices (second device used without complications).On an unknown date in february 2023 (reported as "this week"), the patient was inserted with vacuum-induced hemorrhage control system (jada system) (device number 1) via vaginal route by provider for uterine hemorrhage (uterine haemorrhage).It was reported that after 30 minutes of usage, there was a clot in the suction tubing and the provider removed the vacuum-induced hemorrhage control system (jada system) (device number 1) and found clots in the intrauterine loop as well that were compromising the suction of the vacuum-induced hemorrhage control system (jada system) (device number 1) (device occlusion and device ineffective) and on the same day, the provider then placed a second vacuum-induced hemorrhage control system (jada system) (device number 2), and it performed as expected without complication.It was reported that the patient sought medical attention.The availability of vacuum-induced hemorrhage control system (jada system) (device number 1) was unknown.For vacuum-induced hemorrhage control system (jada system) (device number 1), lot number and serial number were not available.Upon internal review, the events device occlusion and device ineffective were determined to be 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): 4648 insufficient information (there is not yet enough information available to classify the health impact).Fda code: (health effects - health impact per annex f): 4641 unexpected medical intervention (patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan.).

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: 16901781
• MDR Text Key: 314902202
• Report Number: 3002806821-2023-00049
• 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: 05/10/2023

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: 05/10/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female