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 11/20/2022

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

Device ineffective [device ineffective].Case narrative: this initial spontaneous report originating from the united states, was received from a clinical account specialist (cas), referring to a female patient of unknown age.The patient¿s historical condition was not reported.The patient¿s current condition included thrombin issue.Concomitant medications were not reported.This report concerns 1 patient and 2 devices.On an unknown date in (b)(6) 2022, the patient was started on vacuum-induced hemorrhage control system (jada system # 1) (lot# was not reported) for post partum hemorrhage (pph).On (b)(6) 2022 (reported as cas learned of this report with in 24 hours), the reporter stated that she "overheard nurses talking" after a vacuum-induced hemorrhage control system (jada system # 1) refresher inservice and learned that this provider "had a patient that he used the vacuum-induced hemorrhage control system (jada system # 1) on and it did not stop the bleeding" (device ineffective).Per report, the provider ended up removing the vacuum-induced hemorrhage control system (jada system # 1) and inserting a bakri, which was also ineffective, before removing the bakri and inserting vacuum-induced hemorrhage control system (jada system # 2) once more.Per report, after the second vacuum-induced hemorrhage control system (jada system # 2) insertion (lot # was not reported) for pph and "the bleeding slowed some", but patient "ended up in intensive care unit (icu) and with a hysterectomy".The patient had a ("thrombin issue"), but no other details are known.The availability of the vacuum-induced hemorrhage control system (jada system # 1 & # 2) for evaluation was unknown.Upon internal review, the event of "device ineffective" was determined to be serious as it required intervention.Medical device reporting criteria: serious injury.(b)(4).

• 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: 15879915
• MDR Text Key: 304468580
• Report Number: 3002806821-2022-00016
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• PMA/PMN Number: 510K K201199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2022

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: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female