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 09/18/2023

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

A clot had formed in the tube that extends from the loop to the vacuum tubing.It was in the tube before the vacuum connector [device occlusion].Case narrative: this spontaneous report originating from the united states was received from a nurse via clinical account specialist (cas) and designated point of contact (dpoc), referring to a female patient of an unknown age.The patient's current condition included hospitalization.Her historical conditions, past drugs/ allergies and concomitant medications were not reported.This report concerns 1 patient and 1 device.On (b)(6) 2023, the patient was placed with vacuum-induced hemorrhage control system (jada system) via an unknown route for an unknown indication.It was reported that upon taking the patient from the operating room (o.R.) to the post-anesthesia care unit (pacu), the vacuum was unplugged and then re-attached to the vacuum system in the pacu.A clot had formed in the tube that extended from the loop to the vacuum tubing.It was in the tube before the vacuum connector (device occlusion, onset date: (b)(6) 2023).The reporter asked what was supposed to be done in this instance, and asked if the device should be replaced.It was also reported that the reporter could not flush it and it was not clearing with the vacuum attached, even with higher pressure on the vacuum.Reportedly, at the time of reporting the patient was in the intensive care unit (icu) (considered as prolonged hospitalization).It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not provided.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.Therefore, priority quality investigation will not be completed.Medical device reporting criteria: serious injury.Fda code: (health effects - health impact per annex f): 4608 patient requires admission to or extension of stay in an intensive care unit.

• 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: 17787675
• MDR Text Key: 323908059
• Report Number: 3002806821-2023-00110
• 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: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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): Hospitalization
• Patient Sex: Female