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 03/13/2023

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

Device failed to control bleeding [device ineffective].Large clot was hindering the suction of blood [device occlusion].Case narrative: this initial spontaneous report originating from the united states, was received from a nurse educator via jada clinical educator referring to a non-pregnant female patient of unknown age.The patient's historical conditions included caesarean section.The patient's concurrent conditions included hospitalization and post-delivery hemorrhage.Concomitant medications were not reported.This report concerns 1 patient and 1 device.On (b)(6) 2023 (reported as yesterday), physician placed vacuum-induced hemorrhage control system (jada system) via vaginal route (lot# and expiration date were not reported) for post-delivery hemorrhage (postpartum hemorrhage).Nurse educator stated device failed to control bleeding (device ineffective).After vacuum-induced hemorrhage control system (jada system) was removed it appeared that a large clot was hindering the suction of blood (device occlusion).The therapy with vacuum-induced hemorrhage control system (jada system) was discontinued on same day.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.Medical attention was requested.No additional adverse event (ae) or product quality complaint (pqc) reported.Upon internal review, the event of device ineffective was considered to be medically significant.Medical device reporting criteria: serious injury.Fda code: (health effects - health impact per annex f): (4648) there is not yet enough information available to classify the health impact.Fda code: (health effects - health impact per annex f): (4641) patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan.

• 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: 16610239
• MDR Text Key: 311959619
• Report Number: 3002806821-2023-00029
• 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: 03/24/2023

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: 03/24/2023
• 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): Other
• Patient Sex: Female