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 04/06/2023

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

Provider performed a "very vigorous fundal massage and the jada device came out of the patient with the balloon still intact [device expulsion] case narrative: this initial spontaneous report originating from the united states, was received from a clinical educator via clinical account specialist (cas), referring to a non-pregnant female patient.The patient's medical history included pregnancy and delivery.Her concurrent conditions, past drugs/allergies, and concomitant medications were not reported.The patient had lost 2100 cc of blood at delivery prior to use of vacuum-induced hemorrhage control system (jada system).This report concerns 1 patient and 1 device.On (b)(6) 2023, the patient underwent vacuum-induced hemorrhage control system (jada system) via vaginal route (lot# and expiry date were not reported) placement by the provider for postpartum hemorrhage.It was reported that the suction was on and working and the canister was filling.The provider performed a "very vigorous fundal massage and the vacuum-induced hemorrhage control system (jada system) device came out of the patient with the balloon still intact" (device expulsion).The patient sought medical attention and ended up with a hysterectomy.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.Upon internal review, the event of device expulsion was determined to be serious due to the following reasons: medically significant and 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): 4624 surgical intervention (one or more surgical procedures was required, or an existing procedure changed).

• 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: 16866494
• MDR Text Key: 314528361
• Report Number: 3002806821-2023-00046
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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): Other; Required Intervention
• Patient Sex: Female