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 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

Clot occluding the intrauterine loop [device occlusion].Case narrative: this spontaneous report originating from the united states was received from a physician via clinical sales educator (cse), referring to a female patient of an unknown age.The patient's medical history included term vaginal delivery section with high quantitative blood loss (qbl) of approximately 2 liters and pregnancy.Her current conditions, concomitant medications 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 intrauterine route for postpartum haemorrhage, however, a clot occluded the intrauterine loop (device occlusion), despite sweeping the uterus.Device was removed and a new vacuum-induced hemorrhage control system (jada system) was placed, which worked just fine.No further information was provided.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 occlusion was considered to be 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): additional device required 4642 use of an additional or alternative device require to achieve optimal outcome.

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

Clot occluding the intrauterine loop [device occlusion].Case narrative: this spontaneous report originating from the united states was received from a physician via clinical sales educator (cse), referring to a female patient of an unknown age.The patient's medical history included term vaginal delivery section with high quantitative blood loss (qbl) of approximately 2 liters and pregnancy.Her current conditions, concomitant medications 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 intrauterine route for postpartum haemorrhage, however, a clot occluded the intrauterine loop (device occlusion), despite sweeping the uterus.Device was removed and a new vacuum-induced hemorrhage control system (jada system) was placed, which worked just fine.No further information was provided.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 occlusion was considered to be 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): additional device required 4642 use of an additional or alternative device require to achieve optimal outcome.

• 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: 17539454
• MDR Text Key: 321051459
• Report Number: 3002806821-2023-00097
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/16/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female