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); No Clinical Signs, Symptoms or Conditions (4582)

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

Blood was noted to be leaking around the seal [device ineffective].The cervical seal was not emptied prior to release of suction [wrong technique in device usage process].No additional ae identified [no adverse event].Case narrative: this spontaneous report originating from united states was received from a other health professional (nurse) via clinical account specialist (cas) (clinical account specialist (cas) reporting on behalf of other healthcare provider) referring to a female patient of unknown age.The patient's concurrent conditions, past medical history, concomitant medications, past drugs and past drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.On an unknown date, the patient was placed with vacuum-induced hemorrhage control system (jada system) via vaginal route (lot and expiration date were not reported) for an unknown indication.On an unknown date, the nurse reported that during the 30-minute safety check they turned off the suction but did not deflate the cervical seal and blood was noted to be leaking around the seal (device ineffective) due to this the hospitalization was prolonged.After some time, the suction was reattached, and the nurse was asking how long they could leave the vacuum on again.The cervical seal was not emptied prior to release of suction (wrong technique in device usage process).The clinical account specialist (cas) instructed nurse on proper instructions for use.Provider information was unknown.No additional adverse event (no adverse event) and product quality complaint were identified.The patient sought medical attention.Therapy with vacuum-induced hemorrhage control system (jada system) was discontinued.The outcome of device ineffective was unknown.Upon internal review, the event device ineffective was considered to be medically significant.Medical device reporting 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.

Event Description

The cervical seal was not emptied prior to release of suction [wrong technique in device usage process] no additional ae identified [no adverse event] case narrative: this spontaneous report originating from united states was received from a other health professional (nurse) via clinical account specialist (cas) (clinical account specialist (cas) reporting on behalf of other healthcare provider) referring to a female patient of unknown age.The patient's concurrent conditions, past medical history, concomitant medications, past drugs and past drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.On an unknown date, the patient was placed with vacuum-induced hemorrhage control system (jada system) via vaginal route (lot and expiration date were not reported) for an unknown indication.On an unknown date, the nurse reported that during the 30-minute safety check they turned off the suction but did not deflate the cervical seal and blood was noted to be leaking around the seal (device ineffective) due to this the hospitalization was prolonged.After some time, the suction was reattached, and the nurse was asking how long they could leave the vacuum on again.The cervical seal was not emptied prior to release of suction (wrong technique in device usage process).The clinical account specialist (cas) instructed nurse on proper instructions for use.Provider information was unknown.No additional adverse event (no adverse event) and product quality complaint were identified.The patient sought medical attention.Therapy with vacuum-induced hemorrhage control system (jada system) was discontinued.The outcome of device ineffective was unknown.Upon internal review, the event device ineffective was considered to be medically significant.Medical device reporting 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.Follow up information was received from a other health professional (nurse) via clinical account specialist (cas) (clinical account specialist (cas) reporting on behalf of other healthcare provider) on 05-apr-2024.Previously reported event "device ineffective" has been deleted since per follow up information vacuum-induced hemorrhage control system (jada system) was able to stop the bleeding.The patient's medical history included anemic (anaemia), pre-eclampsia, g2 (gravida ii), p2 (parity 2), uterine atony, retained placenta, twins (twin pregnancy) and vaginal (vaginal delivery) (35 weeks and something).The patient's historical drugs included carboprost trometamol (hemabate), angiotensin 1-7(txa) and misoprostol (cytotec).The patient had not given a live birth in the past.The delivery was induced.Had epidural agents used.There was invasive placenta which had membranes left inside.There was the 2600 ml estimated blood loss (ebl/qbl) prior to vacuum-induced hemorrhage control system (jada system) use.The vacuum-induced hemorrhage control system (jada system) device stop controls the bleeding.Time of vacuum connection to control of bleeding was maybe 2-3 hours.After initial bleeding control by vacuum-induced hemorrhage control system (jada system), there was not another bleeding episode.200 ml blood was collected in the vacuum-induced hemorrhage control system (jada system) canister.No more than one vacuum-induced hemorrhage control system (jada system) device used.The operator of the device was attending physician and resident physician.The device was not removed and reinserted for any reason.The ultrasound used to evaluate during vacuum-induced hemorrhage control system (jada system) use for placing and retained placenta, there was no maternal admission to icu (intensive care unit) required.The patient was not diagnosed with endometritis.This case has been downgraded from serious to non-serious since previously reported event "device ineffective" has been deleted.Device review completed.This case has been downgraded and no longer meets criteria for device reportable event.

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.This case has been downgraded per internal review and no longer meets criteria for device reportable event.The report is being submitted one last time.

• 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: 19070285
• MDR Text Key: 339702830
• Report Number: 3002806821-2024-00029
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

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
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/17/2024
• 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; Hospitalization
• Patient Sex: Female