MAUDE Adverse Event Report: ORGANON & CO. JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Insufficient Information (4580)

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

There was still bleeding around the seal [device ineffective].Misplaced seal [device placement issue].Case narrative: this spontaneous report originating from united states was received from a registered nurse via clinical account specialist (cas), referring to a non-pregnant female patient of unknown age.The patient's concurrent condition included uterine atony (lower segment).The patient's medical history and past drugs/ allergies were not reported.Her concomitant medications included oxytocin and poliglusam (chitosan) (reported as " chitosan packing").Prior to vacuum-induced hemorrhage control system (jada system) placement, she lost about 510 cc of blood.This report concerns 1 patient and 1 device.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system (jada system) via intrauterine route for postpartum hemorrhage.Reportedly, the device came in a white carton.The device initially drained 60 cc in the canister.Fundal massage was done, and misplaced seal (device placement issue) was repositioned, then 450 cc of blood was drained within one hour.There was still bleeding around the seal (device ineffective), and therefore, the vacuum-induced hemorrhage control system (jada system) was discontinued after one hour of usage.The patient was given methergine (discrepancy; also reported as "given prior to device").After methergine was given the fundus was firm.The suspected cause of the postpartum hemorrhage was reported as uterine atony.No additional adverse event (ae)/ product quality complaint (pqc) was reported.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.For vacuum-induced hemorrhage control system (jada system), the lot # and serial # were not available.Upon internal review the event of device ineffective was considered as serious as it required intervention.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.Fda code: (health effects - health impact per annex f): 4641 unexpected medical intervention (patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan).

• 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: 17246231
• MDR Text Key: 318442123
• Report Number: 3002806821-2023-00076
• 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: 07/03/2023

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: 07/03/2023
• 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
• Treatment: CHITOSAN [POLIGLUSAM] (CHITOSAN [POLIGLUSAM]).; OXYTOCIN (OXYTOCIN).
• Patient Outcome(s): Required Intervention
• Patient Sex: Female