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 05/01/2023

Event Type  Injury  

Event Description

Patient continued to have bleeding with device so it was removed and patient was taken to the or and a d&c was performed [device ineffective].The product would slip out of the uterus [device expulsion].Difficulty inserting the product and keeping it within the uterus [device placement issue].Potential misuse of product/was the device used according to the leaflet: no [wrong technique in device usage process].Case narrative: this initial solicited report originating from the united states, was received from a physician via designated point of contact (dpoc), referring to a non-pregnant female patient of unknown age who was enrolled in a market research program entitled "jada qualitative research on jada use within community/rural hospitals" (discrepancy; also reported as "jada community hospital market research"), conducted by trinity life sciences.The patient's concurrent condition included bladder prolapse.Her medical history and concomitant therapies were not reported.This report concerns 1 patient and 1 device.On an unknown date, the physician inserted vacuum-induced hemorrhage control system (jada system) via unknown route for postpartum haemorrhage (pph).It was unknown if the operator was trained.The physician reported that due to the weakened walls (presumably due to bladder prolapse), the product would slip out of the uterus (device expulsion, onset date: unknown).It was also reported that there was difficulty inserting the product and keeping it within the uterus (device placement issue, onset date: unknown).It took the physician a few attempts and managing the suction to get the device to stay in.A potential misuse of product was anticipated as it was reported that the device was not used according to the leaflet (wrong technique in device usage process, onset date: unknown).There were no negative impacts on the patient.It was also reported that no prescription drug treatment was required for the experience, and it was not life-threatening.There was no hospitalization, and no significant disability/incapacity.No product quality complaint (pqc), and no additional adverse event (ae) were reported the vacuum-induced hemorrhage control system (jada system) was not available for evaluation as it was disposed of after use.Upon internal review, the event of device expulsion was determined to be medically significant.The reporter considered the event of device expulsion as serious as it required intervention (discrepancy; also reported that "medical/surgical intervention was not required").Fda code: (health effects - health impact per annex f): 2199 no health consequences or impact (no apparent harm occurred in relation to the adverse event).Follow up information was received from registered nurse (previously reported as "physician") on (b)(6) 2023.It was reported that this was patient's second pregnancy.Current pregnancy type was singleton, vaginal delivery, and the newborn was full term.The patient's last menstrual period (lmp) was considered as 2022.The nurse was unsure if delivery was induced but patient did receive an epidural.The interventions given prior to vacuum-induced hemorrhage control system (jada system) use was oxytocin, carboprost trometamol (hemabate) (reported as "hemobate"), and methylergometrine maleate (methergine) (reported as "methogin").This report concerns 1 patient and 2 devices (second device was successful).Nurse reported that patient experienced postpartum bleeding and the provider placed the bulb.Suspected cause of postpartum hemorrhage was unknown.Nurse states the patient had a severely prolapsed bladder which was believed to have caused the cervical cuff to come out.On an unknown date in (b)(6) 2023 (reported as "within the last 2 weeks"), the patient was inserted with vacuum-induced hemorrhage control system (jada system) (device number 1), it was connected to suction for 2 hours and she continued to have bleeding with device (device ineffective) so it was removed and patient was taken to the operating room (or) and a dilation and curettage (d&c) was performed.The event onset for all the events were updated to unknown date in (b)(6) 2023.Nurse stated that the patient was placed in trendelenburg position, the "bladder was pushed back up", and a new vacuum-induced hemorrhage control system (jada system) (device number 2) was placed and connected to suction for 8 hours.Nurse stated that second device was successful as long as patient was kept in a good position.Nurse reported the vacuum-induced hemorrhage control system (jada system) devices came in a green carton, but lot number was unknown.Additionally, event of no adverse event was deleted.Upon internal review, the event of device ineffective was considered as serious due to 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): 4624 surgical intervention (one or more surgical procedures was required, or an existing procedure changed).

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: 17037064
• MDR Text Key: 316387881
• Report Number: 3002806821-2023-00066
• 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: Other,Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: 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
• Treatment: HEMABATE (CARBOPROST TROMETAMOL).; METHERGINE (METHYLERGOMETRINE MALEATE).; OXYTOCIN (OXYTOCIN).
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female