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 Hemorrhage/Bleeding (1888)

Event Date 09/01/2023

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

The jada failed to stop bleeding [device ineffective].Case narrative: this spontaneous report originating from united states was received from a facility clinical educator (ce) via clinical account specialist (cas), referring to a female patient of unknown age.The patient's medical history, concurrent conditions, concomitant medications, and drug reactions/allergies were not reported.This report concerned 1 patient and 1 device.On unknown date approximately in (b)(6) 2023 (reported as last week (specific date unknown), the patient had placement with vacuum-induced hemorrhage control system (jada system) (lot# and expiration date were not reported) to stop bleeding, but the vacuum-induced hemorrhage control system (jada system) failed to stop bleeding (device ineffective).Clinical account specialist (cas) had very limited information and had attempted to gather further information however the facility clinical educator (ce) refused to inform and also refused to let the clinical account specialist (cas) back into the facility to do any further training.Clinical educator stated that they do not need any further assistance, as they were fine.No further information provided, no additional adverse event (ae) reported, no product quality complaint (pqc) reported.For vacuum-induced hemorrhage control system (jada system), the lot number and the serial number were not available.Upon internal review, the event device ineffective was considered to be medically significant.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.Therefore, priority quality investigation will not be completed.Fda code: (health effects - health impact per annex f): 4648 insufficient information (there is not yet enough information available to classify the health impact).This is one of the two reports received from the same reporter.

• 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: 17828751
• MDR Text Key: 324405456
• Report Number: 3002806821-2023-00117
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2023

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/27/2023
• 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