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 Insufficient Information (4580); 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

Resident used air to inflate the cervical seal for that case [wrong technique in device usage process].No additional ae identified [no adverse event].Case narrative: this spontaneous report originating from united states was received from a consumer via clinical account specialist (cas) referring to a female patient of unknown age.The patient's medical history, concurrent conditions, past drug reactions/allergies and concomitant medications were not reported.This report concerns 1 patient(s) and 1 device(s).On unknown date, the patient was inserted with the vacuum-induced hemorrhage control system (jada system) via vaginal route (batch/lot# and expiry date were not reported) for unknown indication.On an unknown date, a vacuum-induced hemorrhage control system (jada system) was used, and resident used air to inflate the cervical seal (wrong technique in device usage process).The patient was hospitalized and received treatment.The scrub tech was asking if they could use air to fill the cervical seal instead of sterile water.It was reported that she tried to tell the resident (unknown name) that the cervical seal must be filled with sterile water, and the resident responded that ¿no, air was fine¿.Clinical account specialist clarified that sterile water must be used per the instructions for use and requested the scrub tech to report this incident to the unit manager.No additional information was available at this time.No additional adverse event identified (no adverse event), and no product quality complaint identified.The patient sought medical attention.Therapy with vacuum-induced hemorrhage control system (jada system) was discontinued.For vacuum-induced hemorrhage control system (jada system), the lot number and the serial number was not available.Medical device reporting criteria: serious injury.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.

• 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: 19049531
• MDR Text Key: 339467209
• Report Number: 3002806821-2024-00026
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/05/2024

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?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2024
• 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): Hospitalization
• Patient Sex: Female