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  

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 was working successfully, tone was returned to uterus, but a few minutes later it was noted the patient was having vaginal bleeding around the device and the uterus lost tone [device effect incomplete].Case narrative: this initial spontaneous report originating from united states was received from a nurse manager via clinical educator referring to a non-pregnant female patient of unknown age.This report concerns 1 patient and 1 device.The patient¿s medical history included pregnancy and the patient was admitted for scheduled caesarean section (c-section), reason was unknown, was 6 centimeters (cm) dilated but not in active labor.The c-section performed without any issues and delivery was not induced, but the patient started bleeding and multiple unknown medications were administered in an attempt to slow bleeding unsuccessfully.The reporter stated the chart showed the patient had estimated blood loss (ebl) between 4000-5000 milliliter (ml) prior to the insertion of vacuum-induced hemorrhage control system (jada system) device.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system (jada system) via intravaginal route for postpartum hemorrhage (postpartum haemorrhage).The amount of fluid placed in vaginal seal was unknown.The nurse manager stated that the device was working successfully, tone was returned to uterus but a few minutes later it was noted the patient had vaginal bleeding around the device and the uterus lost tone (device effect incomplete).The blood collected in the vacuum-induced hemorrhage control system (jada system) canister was 110 ml.The nurse manager stated no trouble shooting techniques were performed.It was reported that at some point prior to hysterectomy the patient did receive blood products, amount, and exact product unknown.The nurse manager also stated she did not know the patient¿s platelet count.The patient ended up having hysterectomy.The patient sought medical attention.The patient did not die.The device was not removed and was not reinserted for any reason.It was reported that more than one vacuum-induced hemorrhage control system (jada system) was not used.On an unknown date, therapy with vacuum-induced hemorrhage control system (jada system) was discontinued.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not available.Upon internal review, the event of device effect incomplete was considered as serious due to required intervention.Medical device reporting criteria: (b)(4).

• 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: 16240162
• MDR Text Key: 308083033
• Report Number: 3002806821-2023-00004
• 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: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Patient Weight: 68 KG