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 Type  Injury  

Event Description

Jada hooked up to suction on a patient but there¿s a clot in jada [device occlusion] we looked on the program and can¿t see any directions on how to flush a clot out of the jada without it going back up into the bulb.Device issue.Case narrative: this spontaneous report originating from united states was received from a registered nurse via (b)(6) referring to a female patient of unknown age.The patient's concurrent conditions, concomitant medications, medical history, and past drug reactions/allergies were not reported.This report concerned 1 patient and 1 device.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system (jada system) for an unknown indication which had a clot in it due to which vacuum-induced hemorrhage control system (jada system) was hooked up to suction (device occlusion) and vacuum-induced hemorrhage control system (jada system) needs to be flushed but was unable to locate instructions regarding how to flush a clot out of the vacuum-induced hemorrhage control system (jada system) without going back up into the bulb (device issue).No additional adverse event was captured as the nurse was actively treated the patient.For vacuum-induced hemorrhage control system (jada system), the lot number was not available and the serial number was not available.The vacuum-induced hemorrhage control system (jada system) was available for evaluation.Upon internal review, the event of device occlusion was determined to be medically significant.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): 4648 insufficient information (there is not yet enough information available to classify the health impact).

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: 17441368
• MDR Text Key: 320206381
• Report Number: 3002806821-2023-00094
• 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: Other,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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