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 Type  Injury  

Event Description

The jada system did not work and there was blood coming out from our the cervical seal and the patient continued to bleed [device ineffective].The vacuum pores were clogged with clots in them [device occlusion].Case narrative: this spontaneous report originating from the united states was received from a physician via clinical educator, referring to a female patient.The patient's medical history, concomitant medications and drug reactions/allergies were not reported.The patient's concurrent conditions included disseminated intravascular coagulation (dic) prior to the insertion of vacuum-induced hemorrhage control system (jada system).The patient was pregnant (pregnancy) and had delivery.This report concerned 1 patient and 1 device.On an unknown date, the patient underwent vacuum-induced hemorrhage control system (jada system) insertion via vaginal route (lot# and expiration date were not reported) for postpartum bleeding (postpartum hemorrhage).The patient continued to bleed, and the blood came out from the cervical seal and the vacuum-induced hemorrhage control system (jada system) did not work and did not control the bleeding (device ineffective), and it was removed.It was observed that the vacuum pores were clogged with clots in the vacuum-induced hemorrhage control system (jada system) (device occlusion) and the physician (provider) used the bakri balloon as an escalating treatment to stop/ control the abnormal postpartum uttering bleeding/ hemorrhage.It was reported that the patient sought medical attention.It was reported that operator of the device was the attending trained physician who was not a first-time user and received training on the usage of vacuum-induced hemorrhage control system (jada system) on an unknown date.The provider did not mention if any blood products were used during peripartum period.The device was not removed and reinserted for any reasons.It was reported that the vacuum-induced hemorrhage control system (jada system) came in a blue seal valve, kit, and green carton.For vacuum-induced hemorrhage control system (jada system), the serial number was not available.Therapy with vacuum-induced hemorrhage control system (jada system) was discontinued.The outcome of device ineffective and device occlusion was unknown.The reporter's causality assessment was not provided.Upon internal review, the event ¿device ineffective¿ was determined to be medically significant.Medical device reporting criteria: serious injury.(b)(4).

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: 15853498
• MDR Text Key: 304207369
• Report Number: 3002806821-2022-00011
• 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: Physician
• Type of Report: Initial
• Report Date: 11/23/2022

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: 11/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female