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 11/01/2022

Event Type  Injury  

Event Description

They could not get the suction to work/ they could not achieve suction with the product / did not know if it was a product quality problem [device issue] did not know if it was a product quality problem or an error in the set up of the device [wrong technique in device usage process] case narrative: this spontaneous report originating from united states was received from a director of labor and delivery via company representative, referring to a female patient of unknown age.The patient's concurrent conditions, concomitant medications and drug reactions / allergies were not reported.The patient's medical history included: on an unknown date, the patient became pregnant (pregnancy) and had delivery.This report concerned 1 patient and 1 device.On an unknown date in (b)(6) 2022 (reported as one week ago), the patient underwent vacuum-induced hemorrhage control system (jada system) placement via vaginal route (lot# and expiration date were not reported) for postpartum hemorrhage (postpartum haemorrhage) by an unknown provider.The provider reported that the device / product vacuum-induced hemorrhage control system (jada system) did not achieve the suction (also reported as did not get the suction to work) and they did not know if it was a product quality problem (device issue) or an error in the set-up of the device (wrong technique in device usage process).The company representative would be going for a face to face visit next week (in (b)(6) 2022) to hospital to obtain more details.No patient or device information was known at the time of this report.The provider¿s name was unknown, at the time of this report.No other adverse event (ae) or product quality complaint (pqc) reported at this time.For vacuum-induced hemorrhage control system (jada system), the serial number was not available.Upon internal review, device issue 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: 16005683
• MDR Text Key: 305718784
• Report Number: 3002806821-2022-00025
• 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: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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