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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORGANON & CO. JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM
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ORGANON & CO. JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM Back to Search Results
Lot Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Insufficient Information (4580)
Event Type  Injury  
Event Description
Provider left the jada in place for 2 hours and then removed, after removal the patient bleed approximately 1500ml of blood in 15 minutes [device ineffective].Performed an ultrasound which showed clots but left the jada in place [device use issue].Case narrative: this spontaneous report originating from united states was received from a registered nurse via clinical account specialist (cas), referring to a female patient of unknown age.The patient's current condition, patient's historical condition, concomitant medications and past drug reactions/allergies were not reported.This report concerns 1 patient(s) and 1 device(s).On unknown date, the patient underwent insertion with vacuum-induced hemorrhage control system (jada system) (lot #, serial # and expiration date were not reported) via vaginal route for post-delivery vaginal hemorrhage.On an unknown date, the patient had vaginal bleeding, the provider did a manual vaginal sweep, inserted the vacuum-induced hemorrhage control system (jada system), performed an ultrasound which showed clots but left the vacuum-induced hemorrhage control system (jada system) in place (device use issue).Provider left the vacuum-induced hemorrhage control system (jada system) in place for 2 hours and then removed, after removal the patient bleed approximately 1500ml of blood in 15 minutes (device ineffective).Provider took the patient to the operating room for a d&c (dilatation and curettage) however the provider ended up performing a hysterectomy.Therapy with vacuum-induced hemorrhage control system (jada system) was withdrawn.The outcome of the events was unknown.The causality assessment was not reported.The patient sought medical attention.It was unknown if the vacuum-induced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 number and the serial number were not available.Upon internal review, the event device ineffective was determined to be serious due required intervention (devices).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.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.
 
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
Provider left the jada in place for 2 hours and then removed, after removal the patient bleed approximately 1500ml of blood in 15 minutes [device ineffective] performed an ultrasound which showed clots but left the jada in place [device use issue] case narrative: this spontaneous report originating from united states was received from a registered nurse via clinical account specialist (cas), referring to a female patient of unknown age.The patient's current condition, patient's historical condition, concomitant medications and past drug reactions/allergies were not reported.This report concerns 1 patient(s) and 1 device(s).On unknown date, the patient underwent insertion with vacuum-induced hemorrhage control system (jada system) (lot #, serial # and expiration date were not reported) via vaginal route for post-delivery vaginal hemorrhage.On an unknown date, the patient had vaginal bleeding, the provider did a manual vaginal sweep, inserted the vacuum-induced hemorrhage control system (jada system), performed an ultrasound which showed clots but left the vacuum-induced hemorrhage control system (jada system) in place (device use issue).Provider left the vacuum-induced hemorrhage control system (jada system) in place for 2 hours and then removed, after removal the patient bleed approximately 1500ml of blood in 15 minutes (device ineffective).Provider took the patient to the operating room for a d&c (dilatation and curettage) however the provider ended up performing a hysterectomy.Therapy with vacuum-induced hemorrhage control system (jada system) was withdrawn.The outcome of the events was unknown.The causality assessment was not reported.The patient sought medical attention.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 number and the serial number were not available.Upon internal review, the event device ineffective was determined to be serious due required intervention (devices).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.Fda code: (health effects - health impact per annex f): 4624 surgical intervention (one or more surgical procedures was required, or an existing procedure changed).Follow up information was received on 31-jan-2024: the patient medical history included uterine atony, pregnancy, abnormal postpartum uterine bleeding, cesarean, patient had history of 3 gravida and 3 para.The invasive placenta was suspected with accreta.Patient was admitted to intensive care unit.Estimated total blood loss at delivery was 795 ml.It was reported that the blood products required during peripartum period was 7 units of packed rbcs, 3 units ffp, 1-unit platelets, multiple doses of albumin over the entire course.Uterine atony was the suspected cause of postpartum hemorrhage.Prior to jada, patient received oxytocin per protocol, txa with second dose and methergine given intramuscularly.Jada was used for 2 hours, and it could not control the bleeding.Fda code: (health effects - health impact per annex f): 4608 intensive care (patient requires admission to or extension of stay in an intensive care unit.) fda code: (health effects - health impact per annex f): 4643 blood transfusion (patient required an infusion of whole blood or a blood component directly into the bloodstream.) 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.Case needs to be voided as case got submitted by incorrected ird 24-jan-2024, instead of 23-jan-2024.A new case is created (b)(4) with correct ird.This safety report id has been submitted with an incorrect ird 24-jan-2024 instead of 23-jan-2024.This safety report will be nullified, and the new case is created (b)(4) with the correct ird 23-jan-2024.
 
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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 Key18613366
MDR Text Key334204141
Report Number3002806821-2024-00002
Device Sequence Number1
Product Code OQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
510K K201199
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/14/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Lot NumberUNKNOWN
Is the Reporter a Health Professional? 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 Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
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