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 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

Did not work as expected/caused bleeding around the cervical seal [device ineffective] blood clot was noted in the tubing, estimated to be about 8 inches long/another clot would form [device occlusion] the same jada system was replaced and reconnected to suction [wrong technique in device usage process] case narrative: this spontaneous report originating from the united states was received from a physician via clinical nurse educator (cne) referring to a non-pregnant female patient of an unknown age.This report concerned 1 patient and 1 device.The patient was gravida 1 (g1) and para 0 (p0) and underwent induction labor for elevated body mass index (bmi) and suspected large gestational age (lga).Baby was delivered via uncomplicated cesarean (c)-section.While the patient was in recovery abnormal bleeding started and estimated blood loss (ebl) of 200-300ml occurred before vacuum-induced hemorrhage control system (jada system) was placed.A manual sweep of uterus was performed prior to vacuum-induced hemorrhage control system (jada system) placement.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system (jada system) via intrauterine route by the provider for post-partum hemorrhage according to instructions for use (ifu), with good seal.It was reported blood flow was noted when vacuum-induced hemorrhage control system (jada system) was connected to suction, and blood had been flowing for 1-2 minutes before a blood clot was noted in the tubing (device occlusion).The clot was "estimated to be about 8 inches long" and "caused bleeding around the cervical seal" (also reported as did not work as expected) (device ineffective).Staff attempted to troubleshoot, attempted to move the clot along the tubing, but as soon as that clot was out of the tubing, another clot would form.On an unknown date, vacuum-induced hemorrhage control system (jada system) was removed entirely, and another uterine sweep was performed, removing large clots.The same vacuum-induced hemorrhage control system (jada system) was replaced and reconnected to suction (wrong technique in device usage process) then once again there was temporary blood flow within the tubing before clots began to form.The suction canister collected 500 ml of blood.Provider decided "there was no more time to troubleshoot", the vacuum-induced hemorrhage control system (jada system) was removed.Total ebl estimated to be 2800ml.Bakri balloon was placed, and bakri "was able to control the bleeding".Patient did receive multiple uterotonics that included misoprostol (cytotec), oxytocin (pitocin), methylergometrine maleate (methergine) and tranexamic acid (txa).Patient required no further interventions and was stable once uterine bleeding was controlled.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.For vacuum-induced hemorrhage control system (jada system) lot number and serial number were not provided.Upon internal review, the event of device ineffective was considered to be serious due to required intervention.Mdr reportability 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): 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: 17676084
• MDR Text Key: 322618837
• Report Number: 3002806821-2023-00107
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• 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?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CYTOTEC (MISOPROSTOL),; METHERGINE (METHYLERGOMETRINE MALEATE),; PITOCIN [OXYTOCIN] (OXYTOCIN),; TRANEXAMIC ACID (TRANEXAMIC ACID),
• Patient Outcome(s): Required Intervention
• Patient Sex: Female