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 10/01/2022

Event Type  Injury  

Event Description

Unable to place the jada system appropriately assuming it to be due to user error so it could not be utilized [device placement issue].Did the jada device stop control the bleeding? no [device ineffective].Case narrative: this initial spontaneous report originating from united states, was received from a physician via customer account specialist (cas) referring to a female patient of unknown age.The patient's medical history included pregnancy, caesarean section, and delivery (discrepant information provided: "it was reported that patient was currently pregnant").The patient's concomitant medications, and drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.Approximately on an unknown date in october 2022 (reported as sometime last month), the patient underwent vacuum-induced hemorrhage control system (jada system) placement for post-partum hemorrhaging (postpartum haemorrhage) (lot# was not reported).The vacuum-induced hemorrhage control system (jada system) was unable to be placed appropriately assuming it to be due to user error so it could not be utilized (device placement issue).It was reported that vacuum-induced hemorrhage control system (jada system) did not stop controlling the bleeding (device ineffective).After the removal of the vacuum-induced hemorrhage control system (jada system) the patient was taken to the operating room where a bakri balloon was placed and then the patient went to interventional radiology.The reporting physician was not the health care provider (hcp) who had inserted the vacuum-induced hemorrhage control system (jada system).It was reported that it was believed that vacuum-induced hemorrhage control system (jada system) came with a blue seal valve kit and green carton since the place at which patient underwent vacuum-induced hemorrhage control system (jada system) placement ran out of the white seal valve and carton back in june.It was reported that maternal admission to intensive care unit (icu) was not required.It was reported that not more than one vacuum-induced hemorrhage control system (jada system) was used.It was reported that after removal of vacuum-induced hemorrhage control system (jada system) it was not reinserted and there was hesitancy to open another one.It was unsure if there was invasive placenta.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.The events of device placement issue and device ineffective were considered to be serious as it required intervention.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: 15870880
• MDR Text Key: 304423419
• Report Number: 3002806821-2022-00014
• 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: 11/28/2022

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: 11/28/2022
• 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): Required Intervention
• Patient Sex: Female