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); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2024

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

Jada system was unsuccessful in treating postpartum hemorrhage due to user error device ineffective a provider utilized jada system on a patient after vaginal delivery and reported clotting in the tube device occlusion we went over troubleshooting and figured it was user error.We believe there was not enough fluid in the seal to achieve desire suction device use error we believe there was not enough fluid in the seal to achieve desire suction device malfunction no additional ae, no pqc reported no adverse event case narrative: this spontaneous report originating from united states was received from a other health professional (nurse) via clinical sales educator (cse) referring to a female patient of unknown age.The patient's medical history included vaginal delivery.The patient's concurrent condition included lower uterine segment atony.The patient¿s concomitant medications and past drugs/allergies were not reported.This report concerns 1 patient(s) and 1 device(s).On an unknown date approximately in 2024 (also reported as about one or two months ago), the patient was placed with vacuum-induced hemorrhage control system (jada system) (lot # and expiration date were not reported) via vaginal route for postpartum hemorrhage.On an unknown date approximately in 2024 (also reported as this event occurred about one or two months ago) a provider utilized vacuum-induced hemorrhage control system (jada system) on a patient after vaginal delivery and reported clotting in the tube (device occlusion).Atony returned and the vacuum-induced hemorrhage control system (jada system) was removed.The patient did not require an escalation of care.They went over troubleshooting and figured it was user error (device use error).They believed there was not enough fluid in the seal to achieve desire suction (device malfunction).No additional adverse event, no product quality complaint reported (no adverse event).No additional information provided at this time.The vacuum-induced hemorrhage control system (jada system) was unsuccessful in treating postpartum hemorrhage due to user error (device ineffective).Troubleshooting and education reviewed.Vacuum-induced hemorrhage control system (jada system) device not stopped control the bleeding.The vacuum-induced hemorrhage control system (jada system) worked without issue.Bleeding continued.The device was not removed and reinserted for any reason.Maternal admission to intensive care unit not required.Therapy with vacuum-induced hemorrhage control system (jada system) was discontinued on an unknown date approximately in 2024.Upon internal review, event device ineffective and device occlusion was determined to be medically significant.The availability of the vacuum-induced hemorrhage control system (jada system) (s) for evaluation was unknown.For vacuum-induced hemorrhage control system (jada system) lot number and serial number were not available.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.

• 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: 18958431
• MDR Text Key: 338344652
• Report Number: 3002806821-2024-00023
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• 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
• 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
• Patient Sex: Female