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 system 'did not work' [device ineffective].Jada system did not work/failure to obtain a proper suction and seal/ it was more about product troubleshooting and education needs [wrong technique in device usage process].The suspicion was provider placement error and failure to obtain a proper suction and seal [device placement issue].The suspicion was provider placement error and failure to obtain a proper suction and seal [device malfunction].No additional ae, no pqc reported [no adverse event].Case narrative: this spontaneous report originating from united states was received from a other health professional (nurse) via clinical sales educator (cas) referring to multiple female patients of unknown age.The patient's concurrent conditions, concomitant medications, past drugs/allergies and medical history were not reported.This report concerns multiple patients with multiple devices.On unknown date, the patients were placed with vacuum-induced hemorrhage control system (jada system) (lot # and expiration date were not reported) via vaginal route for postpartum hemorrhage.On an unknown date, a healthcare organization had a committee meeting to review severe postpartum hemorrhage cases which included seven hospitals.During the meeting it was reported a vacuum-induced hemorrhage control system (jada system) did not work (device ineffective).The clinical sales educator (cse) stated the suspicion was provider placement error (device placement issue) and failure to obtain a proper suction and seal (device malfunction).They did not believe it was a result of product failure.It was more about product troubleshooting and education needs (wrong technique in device usage process).The clinical sales educator (cse) did not have the provider's information or the location where this incident occurred, as the reporter did not want to disclose this information.No additional adverse event (ae) (no adverse event), no product quality complaint (pqc) reported.Upon internal review, event device ineffective 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.Medical device reporting criteria: serious 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.

• 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: 18958523
• MDR Text Key: 338346494
• Report Number: 3002806821-2024-00024
• 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
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• 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