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

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

After several times of reapplying suction, the patient continued to have slow blood loss and was taken to interventional radiology.[device ineffective].No additional ae [no adverse event].Case narrative: this spontaneous report originating from united states was received from a physician via medical science liaison (msl) referring to a female patient of unknown age.The patient's medical history, concurrent conditions, past drugs/allergies and concomitant medications were not reported.This report concerns 1 patient(s) and 1 device(s).On unknown date, the patient was placed with vacuum-induced hemorrhage control system (jada system) (lot # and expiration date were not reported) via intravaginal route for postpartum hemorrhage.She also informed msl that a patient was being managed with vacuum-induced hemorrhage control system (jada system) for postpartum hemorrhage, however, anytime the physician would deflate the cervical seal, there would be a slow re-bleed.After several times of reapplying suction, the patient continued to have slow blood loss (device ineffective) and was taken to interventional radiology.No additional adverse event (no adverse event).The outcome of the event device ineffective was unknown.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.Upon internal review, the event of device ineffective was considered as serious due to medically significant and required intervention.This case was linked to same reporter linked cases included (after several times of reapplying suction, the patient continued to have slow blood loss and was taken to interventional radiology (device ineffective) (reported in oars # (b)(4)).Filled the cervical seal with air instead of fluid (wrong technique in device usage process) (reported in oars #(b)(4)).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: 18949770
• MDR Text Key: 338245746
• Report Number: 3002806821-2024-00022
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• 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): Required Intervention; Other
• Patient Sex: Female